MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14; PROSTHESIS, HIP

Catalog Number	00877502802
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent hip revision approximately 1 year and 4 months post implantation due to dislocation.Modular neck, head, and dm bearings were replaced in this surgery.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4): d10: item # 00-7848-012-00, kinectiv modular neck e, lot # 66071396.Item # 110031011, vivacit-e dm bearing 28x42mm, lot # 65055294.Item # 00-7713-009-00, mod ml taper fem st 9.0, lot # 66083639.Item # 110010264, g7 osseoti multihole 52mm e, lot # 65813649.Item # 110024463, g7 dual mobility liner 42mm e, lot # 031510.Item # 00-6250-065-20, trilogy bone scr 6.5x20, lot # j7454436.Item # 00-6250-065-20, trilogy bone scr 6.5x20, lot # j7526175.G2: report source japan.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 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Review of the complaint history identified additional similar complaints for the reported item and the part and lot combination.This complaint cannot be confirmed and a definitive root cause cannot be determined.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 event information available at the time of this report.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, 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 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21909738
• Report Number: 0009613350-2025-00336
• Device Sequence Number: 4009005
• Product Code: LZO
• UDI-Device Identifier: 00889024430297
• UDI-Public: (01)00889024430297(17)330214(10)3143910
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/23/2025

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: 00877502802
• Device Lot Number: 3143910
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown