MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 3, 11MM, SLOPE +; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ 3, 11MM, SLOPE +
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Unspecified Tissue Injury (4559); Aseptic loosening (4883)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal brief, on or about (b)(6) 2011, patient underwent a left total knee arthroplasty due to osteoarthritis in his left knee.During the procedure.Subsequently, on or about (b)(6) 2012, patient underwent a right total knee arthroplasty due to osteoarthritis in his right knee.On or about (b)(6) 2018, patient underwent a left knee revision surgery due to a failed left total knee arthroplasty.Surgeon dictated in his operative pathology finding that "the patient had significant polyethylene wear on the tibial surface." moreover, surgeon indicated "there was gross osteolytic debris.The tibial baseplate was easily extracted and frankly loose.The femoral component, although well fixated, upon removal, there was a significant osteolytic non-contained cavitary defect that extended into the posterior condyle." surgeon revised the exactech components of the patient's left knee implant and implanted a competitors components.
Additional Manufacturer Narrative
Concomitant products: optetrak asy,cr cemented femoral, sz 3 (cat# 230-02-03 / serial# (b)(4)); cemented finned tib.Tra sz 3f/3t (cat# 200-04-33 / serial# (b)(4)); three peg patella 35mm (cat# 200-02-35 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: investigation results - the revision reported may have been the result of polyethylene wear, osteolysis and tibial loosening as stated in the legal documentation.The aseptic (non-infected tibial loosening was likely the result of an insufficient bond between the tibial tray and the bone and/or patient-related conditions.However, this cannot be confirmed as the devices were not returned for evaluation.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis.However, the contribution of loosening and prosthesis wear to the sequence of events cannot be determined as the devices were not available for evaluation and no images or radiographs were provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d4, h4, h6 (remove previous health effect-clinical code, component code, type of investigation, investigation findings) and h11.The revision reported may have been the result of polyethylene wear, osteolysis and tibial loosening.The aseptic (non-infected tibial loosening was likely the result of an insufficient bond between the tibial tray and the bone and/or patient-related conditions.However, this cannot be confirmed as the devices were not returned for evaluation.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis.However, the contribution of loosening and prosthesis wear to the sequence of events cannot be determined as the devices were not available for evaluation and no images or radiographs were 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 3, 11MM, SLOPE +
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15698684
• Report Number: 1038671-2022-01375
• Device Sequence Number: 12321845
• Product Code: JWH
• UDI-Device Identifier: 10885862041074
• UDI-Public: 10885862041074
• 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: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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: 02/03/2013
• Device Model Number: CR TIBIAL INSERT SZ 3, 11MM, SLOPE +
• Device Catalogue Number: 200-63-11
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 11/01/2023; 03/28/2026
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 11/10/2023; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2008
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male