MAUDE Adverse Event Report: ZIMMER GMBH BIOLX OPT HD/ADPT 12/14 40X+7; PROSTHESIS, HIP

Catalog Number	00877704004
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.S&n 68mm shell item# unknown lot# 24bm04497.S&n liner item# unknown lot# 19cm06594.S&n screws x6 item# unknown lot# unknown.Modular zmr item# unknown lot# 63855103.Zmr xl offset 45 x 78mm item# unknown lot# 64013976.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 a patient underwent right total hip arthroplasty after removal of plating system due to prior trauma fracture.10 years later, patient fell and sustained an injury to right hip old incisional site that progressed into an open and draining abscess above.Several unsuccessful aspirates were attempted and then lead to full explant and spacer implantation due to joint infection.Approximately, 4 year later after the fall, patient continues to report ongoing right hip pain and numbness from hip to foot and underwent the second stage of the revision where loosening of the competitor cemented acetabular cup was found and all implants except for the stem were revised with a mix of competitor and zb products.Subsequently, the patient was placed on posterior hip precautions post-operatively and subsequently, bent over to fix a sock and posteriorly dislocated and underwent a closed reduction.A second dislocation, two weeks later, occurred after adjusting shoes and brace.No revision has been reported.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: b4, g3, g6, h2, h3, h6, h11.The reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.The review identified that patient presented to er with right posterior prosthetic hip dislocation.Neurovascular was intact.Doctor bent over to fix his sock and felt a pop in his right hip.After this, patient was adjusting his shoes and brace and felt his hip pop out of place.Patient was wearing his brace during the incident and has been compliant.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as an off label usage as the whole prothesis components are not compatible.Indeed, as per instruction for use, states that due to the acquisition of pre-existing product lines, zimmer biomet has initiated a testing program to evaluate the compatibility of these devices with implants and components made or distributed by all zimmer orthopaedic companies.Only authorized combinations must be used.The reported product was reviewed for compatibility and it was determined that the following implants are not compatible: smith & nephew cup and liner wit zimmer biomet ceramic head.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.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: BIOLX OPT HD/ADPT 12/14 40X+7
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22452494
• Report Number: 0009613350-2025-00547
• Device Sequence Number: 8118650
• Product Code: LZO
• UDI-Device Identifier: 00889024430587
• UDI-Public: (01)00889024430587(17)320830(10)3120602
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 00877704004
• Device Lot Number: 3120602
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 113 KG