MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER FEM HD 28/+3MM T1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Catalog Number	650-1157
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 110031011, vivacit-e dm bearing 28x42mm, lot 67087540, 110024463, g7 dual mobility liner 42mm e, lot 67097635.G2: foreign - event occurred in australia.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent revision surgery approximately four months and one week post implantation due to femoral head fracture.Patient stated he did not fall though had a misstep which was jarring where he caught his body weight on the side where the damaged component.Then, the patient heard a pop and fell to the ground at the time the implant broke.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11.The following section was corrected: d4 - expiration date.The reported event was confirmed by review of radiographs.Radiographs were provided and reviewed by a radiologist.The review identified a right total hip arthroplasty that exhibits fracture of ceramic femoral head component resulting in multiple fragments.Some of these fragments are dispersed within the joint space and others are visualized lateral to the hip at the periphery of a hypodense pseudotumor.Femoral stem component is disassociated from the head component and resides superiorly within the acetabular cup, contacting the liner superiorly implying damage to the bearing and possible damage to the liner.Visual review of the returned ceramic head confirms size and ceramtec etch.Head shows dark marks in the taper hole, flat surface, fractured surfaces, and outer spherical surface.Consistent with metal transfer.No other damage was noted.Further fracture analysis has been performed by optical microscopy.Examination of the fractured head images show potentially asymmetric metal transfer marks within the taper.Post-fracture metal transfer was observed on the articular surface and fracture surfaces.The fracture surfaces are complex and not all fragments were returned for analysis.The primary fracture initiation cannot be determined with certainty.The device history record was reviewed and no discrepancies relevant to the reported event were found.A review of the device manufacturing records confirmed no abnormalities or deviations.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 DELTA CER FEM HD 28/+3MM T1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24679356
• Report Number: 3002806535-2026-00129
• Device Sequence Number: 9706334
• Product Code: LPH
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: 650-1157
• Device Lot Number: 3239775
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male