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	01/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 13 years post initial left tka, the 73 y/o male patient was revised due to poly issues with flaking and delamination.The patella was worn in half.The patient experienced osteolysis issue due to poly wear.The patient was revised to a size 4 cc femoral component.The patella was revised to a 38mm.The liner was revised to a psc size 4, 11mm.The fem augments were also required due to lack of bone.There was a greater than 45 minute surgical delay/prolongation due to the event.The patient did not experience any adverse events as a result of the surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.The devices are not available for evaluation due to the devices were discarded.
Additional Manufacturer Narrative
Section d10: concomitant products - optetrak 3 peg patella cemented, 32mm diameter (cat# 200-02-32 / serial# (b)(6)) - optetrak asymmetric femoral posterior stabilized, cemented size 4, left (cat# 234-02-04 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear and osteolysis.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The root cause of the prosthesis wear and osteolysis cannot be determined as the devices were not returned for evaluation.

• 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: miguel soza
• MDR Report Key: 18739883
• Report Number: 1038671-2024-00269
• Device Sequence Number: 6509439
• 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: 2011
• 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): 05/30/2024

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: 01/17/2019
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2011
• 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: OPTETRAK TIBIAL TRAY TRAPEZOID, CEMENTED SZ 4F/4T
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male