MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HEAD 12/14 32X0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	00877503202
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Subluxation (4525); Joint Laxity (4526)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.G7 vit e neutral lnr 32mm e item# 30103205 lot# 66543400.G2: foreign - event occurred in new zealand.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.
Event or Problem Description
It was reported that the patient underwent a hip revision approximately 4 months post-implantation due to instability.Prior to revision, the patient sustained a fall and experienced subluxation of the joint.The revision was performed using a direct anterior approach technique.Diligence is completed and no further information on the reported event has been provided.

• Brand Name: BIOLOX DELTA HEAD 12/14 32X0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• 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: 25673245
• Report Number: 0009613350-2026-00339
• Device Sequence Number: 13373911
• Product Code: LZO
• UDI-Device Identifier: 00889024430327
• UDI-Public: (01)00889024430327(17)341004(10)3214089
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: 00877503202
• Device Lot Number: 3214089
• 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: 06/04/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 78 YR
• Patient Sex: Unknown