MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-22-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's right knee was revised approximately 14 year 4 months post op.The patella was worn out.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.Product not returning: it was discarded.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was performed and no discrepancies were found.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from orientation of the components, high contact stress, joint instability, and/or from over 14 years of use which led to wear of the patella component and tibial insert.However, this cannot be confirmed because the components were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PS TIBIAL INSERTS SZ 2, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20318577
• Report Number: 1038671-2024-03729
• Device Sequence Number: 7669328
• Product Code: JWH
• UDI-Device Identifier: 10885862048233
• UDI-Public: 10885862048233
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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 Expiration Date: 12/17/2017
• Device Catalogue Number: 204-22-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 234-03-02 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 80 KG