MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	PS TIBIAL INSERTS SZ 3, 15MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, initial knee implanted on (b)(6) 2007, underwent a revision procedure on (b)(6) 2022, approximately 5 years 2 months post the initial implant procedure for poly wear.No further information reported.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After an additional review of information received, the following sections, have been updated for correction accordingly: b5 - implant/explant dates orginally state incorrectly.
Event or Problem Description
Initial knee implanted on (b)(6) 2016, underwent a revision procedure on (b)(6) 2021.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: h6: the revision reported may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, or any combination of these possibilities, which led to prosthesis wear.A contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed as the device was not available for evaluation and pre-revision radiographs/images were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b5, g1, h6 - health effect - clinical code, component code, type of investigation, investigation findings, investigation conclusions, h7 and h11.The revision reported may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, or any combination of these possibilities, which led to prosthesis wear.A contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed as the device was not available for evaluation and pre-revision radiographs/images were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial total knee arthroplasty.Subsequently, it was reported that the patient experienced wear of the tibial insert.As a result, the patient underwent a knee revision approximately 5 years and 2 months after initial implantation.No further patient impact reported.No further information available.

• Brand Name: PS TIBIAL INSERTS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL ; 3523771140
• MDR Report Key: 15628564
• Report Number: 1038671-2022-01323
• Device Sequence Number: 12377737
• Product Code: JWH
• UDI-Device Identifier: 10885862048332
• UDI-Public: 10885862048332
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/16/2026

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: 04/12/2019
• Device Model Number: PS TIBIAL INSERTS SZ 3, 15MM
• Device Catalogue Number: 204-23-15
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 02/28/2023; 04/12/2023; 03/09/2026
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 02/28/2023; 05/01/2023; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2011
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown