MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 4, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: ps cem.Femoral size 4, left (cat# 234-02-04 / serial# (b)(6)).Cemented trapezoid tray 4f/5t (cat# 204-04-45 / serial# (b)(6))0 three peg patella, 35mm (cat# 200-02-35 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately ten years post initial left tka, the 68 y/o male patient had a revision due to poly issues with flaking and delamination.Patient had massive osteolysis issue due to poly wear.Everything was removed.There were parts or pieces of the device that fell into patient wound site and were removed by surgeon.There was a greater than 45 mins surgery delay/prolongation.Patient revised to competitor's devices.Patient was last known to be in stable condition following the event.Images received.The devices are not available for evaluation due hospital refused to properly clean the prosthesis, there was bone and blood still on the components.The explants were discarded.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, instability, or any combination of these possibilities, which led to wear of the polyethylene insert and osteolysis.However, this cannot be confirmed as the devices were not returned for evaluation and images of the explanted devices and pre-revision radiographs were not provided.The most probable root cause associated with the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.Furthermore, the most probable root cause associated with the event of ¿osteolysis¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.

• Brand Name: PS TIBIAL INSERTS SZ 4, 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17025982
• Report Number: 1038671-2023-01173
• Device Sequence Number: 12679716
• Product Code: JWH
• UDI-Device Identifier: 10885862048387
• UDI-Public: 10885862048387
• 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: 2023
• 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): 08/09/2023

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: 02/17/2018
• Device Model Number: PS TIBIAL INSERTS SZ 4, 9MM
• Device Catalogue Number: 204-24-09
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2010
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 80 KG