MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® OPTION, HEAD, M, ø 40/0, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	00877704002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646); Unequal Limb Length (4534); Joint effusion (4849)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.G7 osseoti multihole 56mm f item# 110010266 lot# 6982870.Bone screw self-tapping 6.5 mm dia.25 mm length item# 00625006525 lot# 64894184.Bone screw self-tapping 6.5 mm dia.20 mm length item# 00625006520 lot# 63913605.Bone screw self-tapping 6.5 mm dia.50 mm length item# 00625006550 lot# 63913605.G7 hi-wall e1 liner 40mm f item# 010000942 lot# 8807035.G2: foreign - event occurred in italy.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 that the patient had undergone an initial left total hip arthroplasty approximately 12 years earlier.Around mid-2021, the patient accidentally fell and sustained a small fracture to the acetabular floor beneath the cup.A few months later, radiographic imaging displayed sinking of the cup with evident bone deficit at the acetabular roof, and serum cobalt and chromium levels were elevated.Several months later, the patient underwent an acetabular revision and reactive gray synovitis of a metallosis type at the stem and acetabulum, trunnionosis, and absence of the anterior wall with extensive acetabular osteolysis were found.The fractured bone fragment was synthesized with two cortical screws and all other components were revised except for the stem.Post-operatively, the patient¿s hemoglobin dropped to 7.6 g/dl and required one unit of transfused red blood cells.The patient was undergoing a slow progressive recovery and, several months later, after a short walk with weight bearing, had an onset of pain.Radiographic imaging displayed a periprosthetic fluid collection, resorption of the graft, and cup protrusion, and subsequently the patient underwent an ultrasound-guided aspiration.About a week later, the patient presented to the emergency room and was admitted to the hospital with hip pain, anemia, and hematoma within the iliopsoas muscle, and required blood transfusions during the hospitalization.Later that month, the patient underwent a revision where a large hematoma was evacuated, the cup had migrated and was found without signs of osteointegration, and there was absence of the anterior wall and acetabular floor.During the procedure, an expected venous bleed from the acetabular floor was encountered and corrected by a vascular surgeon.Due to the blood loss, the patient required intra-operative and post-operative blood transfusions for hemodynamic stability.All implants, except the stem, were revised.Following the surgery, the patient remained intubated in the icu for a total of three days and then underwent an uneventful post-operative recovery and was discharged home.Diligence is completed and no further information on the reported event has been provided.

• Brand Name: BIOLOX® OPTION, HEAD, M, ø 40/0, TAPER 12/14
• 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 ; 5745260384
• MDR Report Key: 25248523
• Report Number: 0009613350-2026-00264
• Device Sequence Number: 9597388
• Product Code: LZO
• UDI-Device Identifier: 00889024430563
• UDI-Public: (01)00889024430563(17)310924(10)3085487
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00877704002
• Device Lot Number: 3085487
• 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: 04/30/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2021
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 55 KG