MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 1, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-21-11
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Implant Pain (4561)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a total right knee arthroplasty on (b)(6) 2011 and then approximately 12 years, 11 months later on (b)(6) 2024 the patient had a surgical revision.Revision operative report 8 jan 2024-postoperative diagnosis: aseptic loosening of right total knee.Patient revised to competitor's devices.Patient with radiographic evidence of aseptic loosening of the femoral and tibial components with areas of osteolysis in femur and tibia.Negative for infection.There is evidence of catastrophic polyethylene wear with visual deterioration of the polyethylene with multiple polyethylene fragments throughout the knee.Patella polyethylene component was undermined with areas of osteolysis.The patient was awakened and brought to the recovery room in stable condition.There is no device return.There is no other information provided.
Additional Manufacturer Narrative
D10.Concomitant products: (b)(6) - 200-03-32 - one peg patella 32mm (b)(6) - 200-04-22 - cemented finned tib.Tra sz 2f/2t (b)(6)- 230-03-01 - optetrak asy,cr cemented femoral, sz 1 pending investigation.These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b2 h6 the following sections were corrected: d1 h6 the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening, 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.
Additional Manufacturer Narrative
Report numbers: 1038671-2024-04521 and 1038671-2024-04522 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: b2- both hospitalization - initial or prolonged and required intervention to prevent permanent impairment/damage.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening, 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 1, 11MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 18985313
• Report Number: 1038671-2024-00679
• Device Sequence Number: 2868369
• Product Code: JWH
• UDI-Device Identifier: 10885862040152
• UDI-Public: 10885862040152
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2024

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 Expiration Date: 12/21/2015
• Device Catalogue Number: 200-21-11
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: 11/22/2024; 11/22/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 11/27/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2007
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female