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

Model Number	204-22-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, approximately 5 years post op the initial tsa, this female patient was brought back for left knee pain.The poly insert was removed with significant wear.Both implant were found to be well fixed.A new exactech size 2 15mm insert was implanted.
Additional Manufacturer Narrative
(h3) the revision reported may have been due to third body wear, patient-related conditions, instability, and/or malalignment between the femoral and tibial components, which led to prosthesis wear and pain.Additionally, 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 because the tibial insert was not returned for evaluation and images of the explanted device were unable to be obtained.The following sections have corrected information: (h6) component code: 734, bearings.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been due to third body wear, patient-related conditions, instability, and/or malalignment between the femoral and tibial components, which led to prosthesis wear and pain.Additionally, 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 because the tibial insert was not returned for evaluation and images of the explanted device were unable to be obtained.The product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.".
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Corrected information: b1, b2, h6 clinical code.Updated information: d10, g contact name, facility name/address, g2, g3.D10: (b)(6) - 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.(b)(6) - 200-02-32 - three peg patella 32mm.(b)(6) - 201-78-82 - collar fixation pin 2pk 40mm, quick release (b)(6) - 201-78-88 - 4" drill bit, mod.Hex 2-pk.(b)(6) - 234-02-02 - optetrak asy, ps cemented femoral, sz 2.

• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15240701
• Report Number: 1038671-2022-00923
• Device Sequence Number: 6305199
• Product Code: JWH
• UDI-Device Identifier: 10885862048233
• UDI-Public: 10885862048233
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/30/2025

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: 04/02/2018
• Device Model Number: 204-22-11
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 02/20/2023; 03/08/2024; 01/29/2025
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 03/03/2023; 01/28/2025; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.; UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female