MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 4, 9MM, SLOPE +; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	200-64-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Osteolysis (2377)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 934060 200-04-44 - cemented finned tib.Tra sz 4f/4t.1021260 200-02-38 - three peg patella 38mm.1047606 230-02-04 - optetrak asy,cr cemented femoral, sz 4.1119077 201-78-15 - holding pin mini sharp point 4 pk.1134519 201-78-14 - holding pin headless sharp point long 4pk.78108 203-96-21 - (11-2714) stryker 2000 90x13/21x 1.9mm.Aa1237 asa0030 - sterile disposable containers.Aa1808 13a2101 - cemex system fast genta 70g.
Event or Problem Description
As reported via legal documentation, this patient had left knee replacement on (b)(6)2008.They had left knee revision surgery on (b)(6) 2023, approximately 15 years after their initial implantation.Preoperatively there were signs of some osteolysis around the implant but no clear sign that the implant was loose.However, there was significant narrowing on the medial side of the implant suggesting excessive polyethylene wear.Postoperative diagnosis: polyethylene wear of left total knee replacement with aseptic tibial loosening.Patella component showed some wear but was not extensive.The patella button seemed to be well fixed and was left as is.The polyethylene had worn through completely in the posterior medial corner and had disrupted the locking mechanism on the polyethylene.The femoral component appeared to be fixed, but the tibial component was loose, as it had some motion.There was motion underneath the tray and fluid moving in and out on the medial side.There was a little bit of a osteolytic cyst on the left medial femoral condyle but was contained.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and tibial loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CR TIBIAL INSERT SZ 4, 9MM, SLOPE +
• 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: 17136506
• Report Number: 1038671-2023-01361
• Device Sequence Number: 3930871
• Product Code: JWH
• UDI-Device Identifier: 10885862041104
• UDI-Public: 10885862041104
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: 01/23/2013
• Device Model Number: 200-64-09
• Device Catalogue Number: 200-64-09
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2008
• 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: 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male