MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	200-24-15
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation, this patient had right knee replacement on (b)(6) 2010.Their right knee was revised (b)(6) 2021, approximately 10 years 8 months after their initial procedure.The patient has claimed the following injuries: pain and suffering, past cost of medical care, future cost of medical care, loss of earning capacity and mental and emotional distress.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
D4: added catalog number, expiration date, serial number, and udi d10: (b)(6) 200-02-35 - three peg patella 35mm.(b)(6) 200-02-35 - three peg patella 35mm.(b)(6) 200-04-45 - cemented finned tib.Tra sz 4f/5t.(b)(6) 200-04-55 - cemented finned tib.Tra sz 5f/5t.(b)(6) 200-75-09 - cr tibial insert sz 5, 9mm, slope ++.(b)(6) 200-75-09 - cr tibial insert sz 5, 9mm, slope ++.(b)(6) 230-02-05 - optetrak asy,cr cemented femoral, sz 5.(b)(6) 230-03-04 - optetrak asy,cr cemented femoral, sz 4.G3: added 510k number.H4: added device manufacture date.H6: corrected health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings, and investigation conclusions.Manufacturer narrative updated: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Additionally, the devices were implanted for over ten years prior to the reported failure.However, the reported prosthesis wear could not be confirmed and potential contributions of 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.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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 ; 3523782617
• MDR Report Key: 17224311
• Report Number: 1038671-2023-01496
• Device Sequence Number: 6970078
• Product Code: JWH
• UDI-Device Identifier: 10885862040329
• UDI-Public: 10885862040329
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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
• Device Expiration Date: 07/03/2012
• Device Catalogue Number: 200-24-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown