MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 79MM; PROSTHESIS, KNEE

Model Number	141235
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint effusion (4849)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Year of birth: 1943.Concomitant medical product: unknown femoral component, catalog#: ni, lot#: ni; unknown articular surface, catalog#: ni, lot#: ni.Report source: foreign: germany due diligence is in progress to determine if the device is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty on an unknown date.Subsequently, the patient presented with pain in the knee joint absent of external trauma.X-ray diagnostics detected a fracture of the tibial tray locking bar.Five (5) months post-diagnosis, a revision surgery was performed.Due diligence is in process for this event; to date no further information has been reported.
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty on an unknown date.Subsequently, the patient presented with pain in the knee joint absent of external trauma.X-ray diagnostics detected a fracture of the tibial tray locking bar.Four (4) months post-diagnosis, a revision surgery was performed.The fractured locking bar of the tibial component was replaced as well as the articular surface.The tibial tray remains implanted.Due diligence is in process for this event; to date no further information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: a2; a4; b4; b5; b7; d6a; g3; h2; h6; h10.The following sections have been corrected: b3; d6b.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision op notes: poly lies without irritation, broken clamp appears here- poly and broken clamp removed without complication, tibial and femoral components are firm.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall size and alignment of the implants is appropriate.Normal bone quality.Left total knee arthroplasty with likely implant disassembly of the tibial component.This linear metallic focus posterior to the lateral tibial plateau presumably represents the fractured locking clamp described in the patient's history.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: BIOMET CC CRUCIATE TRAY 79MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16387595
• Report Number: 0001825034-2023-00343
• Device Sequence Number: 12166914
• Product Code: JWH
• UDI-Device Identifier: 00880304008342
• UDI-Public: (01)00880304008342(17)280516(10)J6297905
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2023

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 Model Number: 141235
• Device Catalogue Number: 141235
• Device Lot Number: J6297905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 03/07/2023; 05/04/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/30/2023; 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2018
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 105 KG