MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 40/0, TAPER 12/14; HIP PROSTHESIS

Catalog Number	00877504002
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a hip revision approximately one year post-implantation due to a strange noise inside his body.The liner was found to be broken, but the femoral head was intact.Both liner and head were revised.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: biolox delta taper lnr, #item 00877501340, #lot 3143826.Therapy date: (b)(6) 2025.G2: foreign report source: china.Attempts have been made to gather all product identification information and no further information has been provided.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
Upon receipt of additional information, it has been determined a zimmer biomet device did not cause or contribute to the reported event.This report was submitted in error and should be voided.
Additional Manufacturer Narrative
Follow up report: (b)(4).Updated: b4, b5, d2, g1, g3, g6, h1, h2.Upon receipt of additional information, it has been determined a zimmer biomet device did not cause or contribute to the reported event.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 40/0, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22336965
• Report Number: 0009613350-2025-00456
• Device Sequence Number: 8993965
• Product Code: LZO
• UDI-Device Identifier: 00889024430402
• UDI-Public: (01)00889024430402(17)330526(10)3165592
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K200112
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: Lay User/Patient
• Device Catalogue Number: 00877504002
• Device Lot Number: 3165592
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male