MAUDE Adverse Event Report: EXACTECH, INC. ONE PEG PATELLA 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	ONE PEG PATELLA 26MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: one peg patella 26mm (cat# 200-03-26 / serial# (b)(4)).Rbk cem fin tib tray sz 3f/2t (cat# 260-04-32 / serial# (b)(4)).Optetrak asy hf ps por fem, sz 3, l (cat# 246-02-03 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, this (b)(6) y/o female¿s patella was revised due to undersized and worn out.The lateral edge of the femur was rubbing against the patella and causing pain.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to implants were disposed by hospital.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2, h3 and h6 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of wear of the patella component after being implanted for approximately 11.75 years.It is also possible that the reported wear and pain may have been the result of the surgeon implanting an undersized patella component during the index surgery.However, this cannot be confirmed as the device and immediate post-operative x-rays of the index surgery were not available for evaluation.The most probable root cause associated with the reported event of "prosthesis wear" is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

• Brand Name: ONE PEG PATELLA 26MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12249969
• Report Number: 1038671-2021-00362
• Device Sequence Number: 2840450
• Product Code: JWH
• UDI-Device Identifier: 10885862039637
• UDI-Public: 10885862039637
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ONE PEG PATELLA 26MM
• Device Catalogue Number: 200-03-26
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 81 YR