MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-25-13
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Discomfort (2330); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	05/26/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case ¿ usa.Patient id: (b)(6) + left knee rev 1.(b)(4), lk rev 2, (b)(4), rk rev is associated with this case.It is reported via legal documentation that the patient is verified bilateral knees done by (b)(6), md at (b)(6).Revision left knee #1 on (b)(6) 2016, revision left knee #2 on (b)(6) 2024 and revision right knee (b)(6) 2024.Lk revision 1 op notes: pre/post op diagnosis: failed left total knee replacement secondary to sagittal instability and polyethylene wear with osteolysis.Procedure: revision left total knee replacement, polyethylene exchange.Indications: this is 60-year-old gentleman presented approximately nine years following nonmodular cck total knee replacement with a complaint of recent onset swelling, moderate discomfort in the knee and a sense of instability.On physical examination, he had moderate synovial effusion which was tapped and found to be clear synovial fluid.He had both coronal and sagittal instability with an anterior drawer greater than 10mm with the knee flexed 90 degrees.Operative findings: we found synovial expansion due to what appeared to be polyethylene debris.Ther was no evidence of infection.The tibial and femoral components and patellar components were well fixed.There was significant polyethylene wear of the post with a tibial spacer and there was a large osteolytic defect beneath the medial tibial plateau that extended down in the the metaphysis.It was well corticated and filled with osteolytic soft tissue.Trial insert was sized, tested satisfactory for stability and flexion.Trail was removed and, final component impacted.Patient was awakened and taken to the recovery room in stable condition.The serial number (b)(6) is confirmed to be a part of recall number: z-0019-2022.208-25-13 - cc tibial insert sz 5, 13mm.Serial: (b)(6).510k: k954208.Udi: (b)(4).Product code: jwh.X-ray: no.Operative notes: yes.Concomitant devices: unknown.
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, 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 following sections were updated: h6: type of investigation the following sections were corrected: h6: health effect - clinical code, medical device problem code the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, 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 5, 13MM
• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20246046
• Report Number: 1038671-2024-03585
• Device Sequence Number: 17962459
• Product Code: JWH
• UDI-Device Identifier: 10885862054425
• UDI-Public: 10885862054425
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 03/26/2012
• Device Catalogue Number: 208-25-13
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2007
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male