MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 3, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 234-02-03 optetrak asy,ps cemented femoral, sz 3,-2271668, 200-02-32 three peg patella 32mm-2336108, 204-04-34 trapezoid tibial tray sz 3f/4t-1928871.Device evaluated by mfr: device discarded by the customer.Additional information, including the product investigation, will be submitted within 30 days of receipt,.
Event or Problem Description
It was reported a 75 yo male, initial implant date (b)(6) 2012, underwent a left side knee revision approximately 10 years post initial implant due to poly wear.The poly was exchanged.The patient was last known to be in stable condition following the event.The devices were discarded and are not available for return.
Additional Manufacturer Narrative
H6: the revision reported was likely the result of prosthesis wear over ten years of implantation secondary to contributions from instability and/or implant alignment.The appearance of the tibial insert in the provided image suggests that deformation of the anterior post likely preceded and possibly contributed to wear of the primary articular surface of the tibial insert.However, this cannot be confirmed as radiographs were not available and the device was not received for evaluation.

• Brand Name: PS TIBIAL INSERTS SZ 3, 9MM
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 15052366
• Report Number: 1038671-2022-00811
• Device Sequence Number: 4773207
• Product Code: JWH
• UDI-Device Identifier: 10885862048301
• UDI-Public: 10885862048301
• 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: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2020
• Device Model Number: PS TIBIAL INSERTS SZ 3, 9MM
• Device Catalogue Number: 204-23-09
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2012
• 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: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 80 KG