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

Catalog Number	650-1157
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately two weeks post-implantation, the patient underwent a hip revision due to a periprosthetic fracture.The patient also dislocated their hip as a result of the fracture.The bearing and head dislocated.There was internal fixation of the femur.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10 ¿ 11-300822, arcos 22x150mm spl tpr dist, lot 66549286, 11-301343, arcos con sz c std 80mm, lot 65763357, 110031011, 28mm i.D.42mm o.D.Size e bearing, lot 66842409.G2 ¿ foreign ¿ australia.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, b5, g3, g6, h1, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Radiographs were provided and reviewed by a radiologist.Review of the available records identified the following: there is a left hip arthroplasty with a superolateral dislocation.No fracture is identified.Based on the medical image report, the complaint of dislocation is confirmed.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 CER FEM HD 28/+3MM T1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• 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: 21965875
• Report Number: 3002806535-2025-00179
• Device Sequence Number: 8350774
• Product Code: LZO
• UDI-Device Identifier: 00887868271519
• UDI-Public: (01)00887868271519(17)331212(10)3189493
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/18/2025

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: 650-1157
• Device Lot Number: 3189493
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 79 KG