MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HEAD 12/14 36X0; PROSTHESIS, HIP

Catalog Number	00877503602
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Subluxation (4525); Joint Laxity (4526)
Date of Event	05/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells item#: 00630505036, lot#: 64984774.Modular neck a 12/14 neck taper use with +0 heads only item#: 00784801100, lot#: 63988621.Shell porous with cluster holes 54 mm item#: 00620205422, lot#: 65618053.Bone screw self-tapping 6.5 mm dia.20 mm length item#: 00625006520, lot#: j7375817.Bone screw self-tapping 6.5 mm dia.30 mm length item#: 00625006530, lot#: j7246059.Modular femoral stem press-fit plasma sprayed cementless size 7.5 item#: 00771300700, lot#: 65618572.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 left total hip arthroplasty.Subsequently, approximately 2 years and 4 months post implantation, was revised due to pain, instability, subluxation, and dislocation.During the revision, it was noted the polyethylene was fractured.The head, neck and liner were exchanged without complications.The stem and shell remained implanted.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/corrected.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.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.Complaints are monitored per complaint trending process in order to identify potential adverse trends.The patient was diagnosed with left total hip instability, with a possible polyethylene liner failure.Experienced increased pain after bending down, and radiographs in the er revealed subluxation of the femoral head.Upon follow-up with dr, imaging showed dislocation.A ct scan did not clearly indicate polyethylene failure, but the patient was admitted for a closed reduction (possible open) under general anesthesia with local, with an estimated blood loss of 150cc.Closed reduction achieved with palpable and audible clunk; leg lengths restored, but concern for instability led to open procedure.The hip was found to be unstable and subluxed but not fully dislocated.The femoral head and neck were well-fixed but were explanted.A fracture was noted at the posterior rim of the polyethylene liner.The shell and stem remained well-fixed and intact.Final components were implanted without complications, and x-rays showed no tendency for a lateral and superior subluxation.Images not sent to radiology as the revision notes provide sufficient dictation of findings.Based on the available information, the reported event can be confirmed a definitive root cause could not 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
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: BIOLOX DELTA HEAD 12/14 36X0
• 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: 22336344
• Report Number: 0009613350-2025-00454
• Device Sequence Number: 8994406
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)321024(10)3133330
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: 3133330
• 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: 05/31/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 58 KG