MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 4, 11MM, SLOPE +; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Catalog Number	200-64-11
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377); Implant Pain (4561); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal the patient had a left knee revision on (b)(6) 2013.Approximately 4 years and 6 months after the initial procedure the patient had a left knee revision on (b)(6) 2017.The patient has suffered the following injuries and complications: joint pain, joint swelling and stiffness, tissue damage, polyethylene wear, osteolysis, synovitis.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.The patient has filed a short-form complaint in a multi-district litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044, and pending in the eastern district of new york.Per the transfer order creating this multi-district litigation, ¿plaintiffs¿allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component, which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multi-district litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.
Additional Manufacturer Narrative
Concomitants: (b)(6), 200-03-35 - one peg patella 35mm.(b)(6), 230-02-04 - optetrak asy,cr cemented femoral, sz 4.(b)(6), 200-04-45 - cemented finned tib.Tra sz 4f/5t.(b)(6), 203-88-11 - (11-2954) ao/sodem 90x25x1.27 sawblade.Pending investigation.
Additional Manufacturer Narrative
The reason for the revision reported cannot be determined from the available information but may have been reported at this later time due to inclusion of one of the implanted devices in the packaging recall.However, the reported prosthesis wear/failure could not be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as no images or radiographs were provided, relevant clinical information was not provided, and the devices were not available for evaluation.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: CR TIBIAL INSERT SZ 4, 11MM, SLOPE +
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 ; 3523771140
• MDR Report Key: 17649209
• Report Number: 1038671-2023-02091
• Device Sequence Number: 7449956
• Product Code: JWH
• UDI-Device Identifier: 10885862041111
• UDI-Public: 10885862041111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• 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): 10/11/2024

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: 11/12/2013
• Device Catalogue Number: 200-64-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/11/2024
• Date Device Manufactured: 11/14/2008
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown