FRM022014 - Patient Matched Implant (PMI) Customs Proposal Form Rev 1

Patient Name: Kwena Swartland Physician Name: Duwayne Vermaak Rev: A

Today's Date: 22-May Side: Left Case Number: ZA-20230004

2023
Engineer
Kiefer Bertsch
Name:

The device listed below will be provided by PMI:

Part Description: Materials:
Swartland Left Triflange Sz 24 with Ringloc+ Lock Ti-6Al-4V, Commercially Pure Titanium, Porous
Ring (sterile) Coating

Custom Device Proposal Image(s)

Screw Hole Quantities: Design Features:

Non-
Locking Screws Locking Liner Size 24
Screws
Dome 4 0 Abduction 40°
Ilium 7 0 Anteversion 20°
Ischium 2 0 HA Coating NO
Pubis 0 0

FRM022014 Rev. 1 Approved MC: MC0000232333 Effective Date: 31-Jul-2020

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 FRM022014 - Patient Matched Implant (PMI) Customs Proposal Form Rev 1

Patient Name: Kwena Swartland Physician Name: Duwayne Vermaak Rev: A

All other implants and instruments must be arranged & provided by distributorship including but not limited to:
- Loaner sets "H_TILSC_L" (6.5mm locking screws) and "CP46TRL_L" (short & long drill guides)
- 3.2mm drill bit
- Depth Gauge (00-6611-098-00 or 31-111114)
- 6.5mm non-locking screws (compatible with the shells from the Ringloc+ Acetabular System)
-
Technique(s):
- To fit the Triflange implant in its current location, some bone removal was necessary and a 58mm
Spherical ream was planned. Refer to attached trimmed bone image and/or plastic bone models for
indicated markings.
- Additional information on specific technique for this case will be provided on the Triflange Final Design
Notice.
- For liner trialing, insertion, and removal, as well as non-locking screw insertion, refer to the Ringloc+
Surgical Technique (BMET0239.1).
- PMI locking Screw Technique (BIV0048.0).

Warning(s):
- If there is anything currently in the pelvis that could cause discrepancies during CT reconstruction or
additional bone loss during removal, the Triflange may not fit as designed.
- Patient anatomy may change over time. It is the operating physician's responsibility to determine if the
implant is suitable for the patient. It is recommended that if more than 6 months have passed between
the original CT scan used for implant design and the surgery, an additional CT scan be conducted to
confirm the anatomy.

FRM022014 Rev. 1 Approved MC: MC0000232333 Effective Date: 31-Jul-2020

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