MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14; PROSTHESIS, HIP

Catalog Number	00877503602
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Joint Dislocation (2374)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Tm acet shell 56mm cluster item# 00-6202-056-22 lot# 67050519.Trilogy bone scr 6.5x20 item# 00-6250-065-20 lot# 66481242.Trilogy bone scr 6.5x30 item# 00-6250-065-30 lot# j7728757.Xlpe 0 deg poly liner 56x36 item# 00-6305-056-36 lot# 66890239.Kinectiv modular neck j item# 00-7848-034-00 lot# 64553739.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient had an initial right total hip arthroplasty.Subsequently, 38 days post implantation, was revised due to pain and dislocation.The shell, head, and neck were exchanged without complications.The stem remained implanted.Diligence is completed and no further information on the reported event has been provided.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The reported event could not be confirmed due to lack of product.No product was returned or pictures provided; a product evaluation could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.A definitive root cause cannot 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.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22337791
• Report Number: 0009613350-2025-00457
• Device Sequence Number: 18407214
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)341112(10)3214350
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: 00877503602
• Device Lot Number: 3214350
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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 NARRATJUN 2, 2025IVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 89 KG