MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CERAMIC FEM HD 36/0MM; HIP PROTHESIS

Catalog Number	650-0661
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent revision surgery approximately one-year post-implantation due to hip dislocation and instability.A constrained liner was implanted to address the instability.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 110003634, biolox delta cer lnr 36mm e, lot 3137922.G2: foreign - event occurred in new zealand.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 reported event could not be confirmed due to lack of product/information.The product involved in the reported event was not returned for investigation; however, a picture was provided and shows the head and the liner explanted with blood on.The head exhibits marking which is visually consistent with metal transfer.It is unknown if this occurred from the dislocations or during explant.No further evaluation can be made.A single undated radiograph was received and assessed and not submitted to radiology at this time.Because there is no date, it is unknown when this might have been taken as there is a 1-year timeframe between initial surgery and revision for dislocation.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
No further event information available at the time of this report.

• Brand Name: BIOLOX DELTA CERAMIC FEM HD 36/0MM
• Common Device Name: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23542334
• Report Number: 3002806535-2025-00535
• Device Sequence Number: 9531122
• Product Code: LPH
• UDI-Device Identifier: 00887868271175
• UDI-Public: (01)00887868271175(17)340305(10)3194574
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 02/06/2026

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: 650-0661
• Device Lot Number: 3194574
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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: 40 YR
• Patient Sex: Unknown