MAUDE Adverse Event Report: Zimmer GmbH BIOLOX DELTA HEAD 12/14 36X0; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer

Catalog Number	00877503602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Bursitis (4832)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).\ \ 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 a patient had an initial right total hip arthroplasty.Subsequently, approximately 2 years and 10 months post-implantation, the patient experienced a fall due to an unknown cause and developed pain and mild trochanteric bursitis.The patient treated with ice and oral anti-inflammatories.\ \ attempts have been made and no further information has been provided.

• Brand Name: BIOLOX DELTA HEAD 12/14 36X0
• 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 ; +1(574)526-0384
• MDR Report Key: 50723278
• Report Number: 0009613350-2026-00454
• Device Sequence Number: 10236085
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)320519(10)3115149
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00877503602
• Device Lot Number: 3115149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2022
• 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: Other
• Patient Sex: Male
• Patient Weight: 250 LB
• Patient Race: White