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

Model Number	PS TIBIAL INSERTS SZ 3, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: three peg patella, 200-02-29 - (b)(6).Ps cem.Femoral size 3, left - 234-02-03 - (b)(6).Cem trap tib tray - 204-04-33 - (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the 73 year old female patient had an initial left tka on (b)(6) 2013.The patient was revised on (b)(6) 2024 due to poly issue.The 9mm size 3 liner and 29mm patella were removed and a 9mm size 3 liner and 26mm patella was implanted.There was no reported breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The device is not available for evaluation due to it was disposed at hospital.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses, third body wear, patient-related conditions, instability, or any combination of these possibilities.The reported wear of the tibial insert and the patella was able to be confirmed from the provided photos, but the likely cause could not be determined as the devices were not returned for evaluation and radiographs were not provided.

• Brand Name: PS TIBIAL INSERTS SZ 3, 9MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 19259866
• Report Number: 1038671-2024-01085
• Device Sequence Number: 17812485
• 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: 2013
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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: 12/05/2020
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female