MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 5, 9MM, SLOPE ++; SEE H10

Catalog Number	200-75-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Insufficient Information (4580)
Date of Event	11/10/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Pending investigation.These devices are used for treatment not diagnosis.There is no other information available.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2010.The device is not explanted.There is no other patient demographic or medical history available.No additional information is available.The patient has filed a short-form complaint in a multidistrict 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 multidistrict 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 multidistrict 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
D10: concomitant devices: 1412863, 200-02-35 - three peg patella 35mm; 1895410, 200-02-35 - three peg patella 35mm; 1863163, 200-04-45 - cemented finned tib.Tra sz 4f/5t; 1700843, 200-04-55 - cemented finned tib.Tra sz 5f/5t; 1043619, 200-24-15 - cr tibial insert sz4, 15mm; 1842783, 200-75-09 - cr tibial insert sz 5, 9mm, slope ++; 1842792, 200-75-09 - cr tibial insert sz 5, 9mm, slope ++; 1862367, 230-02-05 - optetrak asy,cr cemented femoral, sz 5; 1865549, 230-03-04 - optetrak asy,cr cemented femoral, sz 4.Conclusions: manufacturer narrative updated: the reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/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.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: CR TIBIAL INSERT SZ 5, 9MM, SLOPE ++
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17563389
• Report Number: 1038671-2023-01979
• Device Sequence Number: 6854505
• Product Code: JWH
• UDI-Device Identifier: 10885862041326
• UDI-Public: 10885862041326
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 200-75-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/17/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown