MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET ILOK PRI TIB TRAY 83MM; PROSTHESIS, KNEE

Catalog Number	141216
Medical Device Problem Codes	Material Erosion (1214); Fracture (1260)
Health Effect - Clinical Codes	Adhesion(s) (1695); Failure of Implant (1924); Synovitis (2094); Metal Related Pathology (4530); Bursitis (4832)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post-implantation, the patient underwent revision surgery as the connection between the tibial tray and tibial stem fractured.Due diligence is in progress for this event; to date no additional information has been reported.
Additional Manufacturer Narrative
(b)(4).D10: medical product: biomet finned pri stem 80x15mm: catalog#: 141320, lot#: 222960; unknown femoral component: catalog#: ni, lot#: ni; unknown articular surface: catalog#: ni, lot#: ni.G2: foreign: germany.Diligence is in process to determine whether the product 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
No further event information at time of this report.
Additional Manufacturer Narrative
D10: medical product: biomet finned pri stem 80x15mm: catalog#141320, lot#222960; unknown 16x79/83mm articular surface: catalog#ni, lot#887550.The investigation is in progress.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: a4; b4; b5; b7; d6a; d9; d10; g3; h2; h6; h11.D10: additional concomitant medical products: unknown femoral component size 75; unknown optipac cement; unknown bone filler the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Approximately three (3) years post-implantation, the patient underwent revision surgery as the connection between the tibial tray and tibial stem and screw fractured.During the revision surgery metallosis was noted due to the fractured and worn components.The femoral component was well fixed and remains implanted.Due diligence is complete and all available information has been provided.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d9; g3; h2; h3; h6; h11.Visual examination of the returned product identified the tibia is fractured with a portion still assembled in the stem implant.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The tibia was submitted for further analysis.Analysis determined one half of the fracture surface showed damaged artifacts, and the other half showed machined lines, which is unusual, and the failure mode couldn't be determined.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 notes: gray colored fluid encountered & metal debris; femoral component not loose - retained; tibia plate removed noted to be fractured and removed easily; screw head broke off smoothly and was able to grasp the protruding (0.5mm) remnant and unscrew; cone is broken and worn by friction; took approximately half hour to remove stem from cemented shaft.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right knee arthroplasty exhibited progressive loosening and eventual disassembly of the modular tibial tray and tibial stem components with migration of the tibial tray component.X-rays demonstrate metal-on-metal corrosion of the tibial tray modular connector component at connection with the tibial stem component, metal synovitis adverse local tissue reaction (altr).Root cause was unable to be determined.Reported event was confirmed by review of provided medical records and evaluation of the returned device.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.

• Brand Name: BIOMET ILOK PRI TIB TRAY 83MM
• 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: 21164542
• Report Number: 0001825034-2025-00157
• Device Sequence Number: 9546178
• Product Code: JWH
• UDI-Device Identifier: 00887868247811
• UDI-Public: (01)00887868247811(17)300124(10)456060
• 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: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/29/2025

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 Catalogue Number: 141216
• Device Lot Number: 456060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 01/28/2025; 05/15/2025; 06/27/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/25/2025; 06/13/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2020
• 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 NARRATIVE.; SEE H11 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 122 KG