MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	CC TIBIAL INSERT SZ 2, 18MM
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Metal Related Pathology (4530); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
Legal case - (b)(6) related cases: (b)(4).As reported via legal documentation: revision surgery (b)(6) 2010, re-revision surgery (b)(6) 2018 approximately 7 years and 10 months after their first revision surgery.Postoperative diagnosis: failed left total knee replacement over the last few months, patient was having increasing pain in the left knee.Multiple aspirations were negative for elevated cell count and all cultures were negative.Imaging was consistent with extensive left knee synovitis with osteolysis, concerning for aseptic osteolytic reaction.The patient was indicated for surgery.Extensive scarring was noted.Extensive grey/black synovium was noted throughout the joint consistent with metallosis reaction.The scarred remnants patellar fat pad was excised.The femoral and tibial implants were not loose.Upon their removal, several underlying, contained areas of osteolysis were identified and curretted out.The patellar button had some delamination of the polyethylene, but was mostly intact, with only slight deformation on the lateral aspect.It was kept in place.Revised to smith and nephew/stryker.Patient was transferred to recovery room in stable condition.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.Serial #: (b)(4).208-22-18 - cc tibial insert sz 2, 18mm, serial number (b)(4).Is confirmed to have been packaged in a vacuum bag that does not contain evoh.
Additional Manufacturer Narrative
Additional information: d5 g4 h3: the revision reported in the case was likely the result of osteolysis as stated in the operative notes.The extent and root cause for the osteolysis cannot be determined at this time as the devices were not available for evaluation, and radiographs and photographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information corrected fields: b1, b2, e1, g1, g2, b7, d10.D10: (1421585) 208-22-18 - cc tibial insert sz 2, 18mm, (1733834) 204-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t, (1823218) 204-32-01 - fluted stem extension 11l x 12 mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: e, b, c, d, g.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
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, instability, dislocation, and loss of range of motion or due to inclusion of the polyethylene in the packaging recall.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: CC TIBIAL INSERT SZ 2, 18MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16727994
• Report Number: 1038671-2023-00662
• Device Sequence Number: 12754371
• Product Code: JWH
• UDI-Device Identifier: 10885862054203
• UDI-Public: 10885862054203
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2014
• Device Model Number: CC TIBIAL INSERT SZ 2, 18MM
• Device Catalogue Number: 208-22-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 01/06/2025; 01/08/2025; 02/21/2025
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 09/12/2023; 01/07/2025; 01/08/2025; 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.; UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female