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

Catalog Number	204-24-09
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a right knee procedure on (b)(6) 2012 and then it was revised on (b)(6) 2019.Patient required revision surgery for issues including but not limited to joint pain, joint swelling and stiffness, tissue damage, polyethylene wear, osteolysis, synovitis, fracture of the tibial component, failure of the polyethylene insert locking mechanism.
Additional Manufacturer Narrative
D10: concomitant devices: 04241 203-96-10 - (11-2325) stryker 2000 90x13mm.050" 1.27mm.1921191 201-78-10 - holding pin headed long 2 pack.1937255 201-78-10 - holding pin headed long 2 pack.2301788 201-78-15 - holding pin mini sharp point 4 pk.2482444 204-04-44 - trapezoid tibial tray sz 4f/4t.2487745 200-02-35 - three peg patella 35mm.2490745 234-03-04 - optetrak asy,ps cemented femoral, sz 4.2w531 203-96-01 - (11-2222) saw blade new stryk (.050).04241 203-96-10 - (11-2325) stryker 2000 90x13mm.050" 1.27mm.H7: recall number (z-0019-2022).H3: the revision reported was likely the result of prosthesis wear of the tibial insert.The cause of prosthesis wear is generally a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, fracture, disassembly, and/or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear, fracture, and disassembly could not be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.H6: corrected health effect, medical device and investigation clinical codes.

• Brand Name: PS TIBIAL INSERTS SZ 4, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19165130
• Report Number: 1038671-2024-00950
• Device Sequence Number: 7873618
• Product Code: JWH
• UDI-Device Identifier: 10885862048387
• UDI-Public: 10885862048387
• 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: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2017
• Device Catalogue Number: 204-24-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 11/30/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2009
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown