MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® OPTION, HEAD, L, ø 32/+3.5, TAPER 12/14; HIP PROSTHESIS

Catalog Number	00-8777-032-03
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an initial right total hip arthroplasty completed on an unknown date with placement of unknown but presumably zimmer biomet product.Subsequently, the patient was revised due to instability, significant gluteal tears were noted which were repaired and the initial head and liner were removed and replaced with known zimmer biomet product at that time.The patient was then ultimately again revised to months after the first revision due to ongoing instability.The cup and liner were exchanged for a constrained construct during this procedure without any noted complications.Further details have not been provided.The head was not explanted but it is involved in the event of instability.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: unk zb cup, #item unknown, #lot unknown.32mm i.D.Size gg elevated rim liner, #item 00885200832, #lot 65580763.Freedom constrained liner, #item unknown, #lot unknown.Therapy date: (b)(6) ,2025.G2: foreign source australia.Attempts have been made to gather all product identification information and no further information has been provided.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
No additional information.
Additional Manufacturer Narrative
Follow up report.(b)(4).Updated: b4, b5, b7, d2, g1, g3, g6, h1, h2, h3, h6.Corrected: d4.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.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records for the revision surgery (implantation of products captured in this complaint were provided and reviewed by a healthcare professional: the revision surgery was performed due to instability under sedation with regional block, using a posterior approach.An 80% gluteal tear was identified, causing subluxation.The head and liner were removed, and a new polyethylene liner and ceramic head were implanted.Stability and leg length were confirmed to be satisfactory.The gluteus minimus and medius tears were repaired, and the wound was closed in layers.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® OPTION, HEAD, L, ø 32/+3.5, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• 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: 22863324
• Report Number: 0009613350-2025-00665
• Device Sequence Number: 18456097
• Product Code: LZO
• UDI-Device Identifier: 00889024430495
• UDI-Public: (01)00889024430495(17)291231(10)3016712
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 10/31/2025

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: 00-8777-032-03
• Device Lot Number: 3016712
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 70 KG