MAUDE Adverse Event Report: ZIMMER GMBH BIOLX OPT HD/ADPT 12/14 32+3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	00877703203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a right hip revision approximately 11 years and 7 months post implantation due to trunnionosis and pseudotumor, followed by a second revision approximately 9 months later for greater trochanter fracture and abductor deficiency.During the first revision, the cup and stem were retained.Subsequently, a second revision was performed in which the cup and stem were again retained, and a cemented constrained liner was placed.Trunnionosis was noted on the trunnion.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
(b)(4).D10.Unknown 12.5 mm extended offset neck femoral stem item# unknown lot# unknown.Unknown 56 mm acetabular component item# unknown lot# unknown.Unknown 35 mm self-tapping screw item# unknown lot# unknown.Trilogy acetabular system liner item# 6310-056-32 lot# 64999470.G2: foreign - event occurred in canada.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.
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.Review of the available records identified the following: ¿ greater trochanter fracture & abductor deficiency (large tear noted); stem found well fixed, retained ¿ removed ceramic head and found trunnionosis ¿ scar tissue removed, cultures sent (no results provided) available information indicates the patient underwent an initial revision procedure for trunnionosis, during which the stem was retained.A subsequent revision was later performed following a greater trochanter fracture, at which time the biolox option head associated with this complaint was revised.Trunnionosis was again noted during the later procedure.Because trunnionosis had already been identified prior to implantation of the biolox option head and remained associated with the same retained stem/trunnion, the available information does not support that the biolox option head caused or contributed to the trunnionosis.The device history record was reviewed and no discrepancies relevant to the reported event were found.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.
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 32+3.5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24079814
• Report Number: 0009613350-2026-00012
• Device Sequence Number: 5790036
• Product Code: LZO
• 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: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00877703203
• Device Lot Number: 3120605
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• 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: 72 YR
• Patient Sex: Male