MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL LONGEVITY; PROSTHESIS, HIP

Catalog Number	00711505028
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a hip revision due to infection and dislocation.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat#6260-9-228 lot #99232607 stryker head.G2: foreign ¿ australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified an explanted head and liner.The devices were covered in bio-debris.No further evaluation could be made from the provided pictures.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided.Review identified the following: dislocation of the femoral head and possible polyethylene liner.It was identified that zimmer biomet liner was implanted with a competitor device.As per ifu 87-6203-760-99, the liner should not be used with components of any other system or manufacturer, unless authorized by zimmer biomet.It is unknown if these off-label usage may have caused or contributed to the reported events.A definitive root cause cannot be identified.The complaint is confirmed.Dislocation is confirmed based on x-ray finding.Infection could not be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: TRABECULAR METAL LONGEVITY
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21292740
• Report Number: 0001822565-2025-00231
• Device Sequence Number: 18441419
• Product Code: KWZ
• UDI-Device Identifier: 00889024130241
• UDI-Public: (01)00889024130241(17)280817(10)65882833
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 05/29/2025

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: 00711505028
• Device Lot Number: 65882833
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female