MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER FEM HD 32/+3MM T1; HIP PROSTHESIS

Catalog Number	650-1161
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: tprlc 133 type1 bm so 10.0; item# 51-113100; lot# 7821184 dural alpha insert neutr gg/32; item # 01.00013.407; lot # 3223772.Allofit alloclassic shl 48/gg; item # 00000004243; lot # 3219562.G2 - foreign: netherlands customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately seven weeks after implantation, the patient underwent a revision surgery due to a femoral head fracture.There was no reported trauma, and the cause of the fracture remains unknown.Due diligence is in progress for this complaint; no further additional information or product has been received at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11.A visual review of the returned ceramic head confirmed that it had fractured.Four fractured pieces were received for evaluation.The pieces show dark marks in the taper hole and on the fracture surfaces, indicating metal transfer.Biological discoloration was also observed on multiple pieces.The visible taper area shows near-circumferential metal transfer, consistent with proper fixation of the head.The fracture surfaces contain metal transfer as well, indicating that the head remained in vivo after the fracture occurred.This likely damaged or obscured key fracture features.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process.Radiographs were provided and reviewed by a radiologist.The review identified that the proximal femoral head implant is fractured and there is mild subluxation of the arthroplasty secondary to the fractured femoral head implant, without dislocation or osseous fracture.There is no evidence of implant loosening.No cause of the femoral head implant is identified.The returned ceramic head exhibited fracture with evidence of near-circumferential metal transfer in the taper area indicating proper fixation.However, with the available information a definitive root cause could not 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 is available at the time of this report.

• Brand Name: BIOLOX DELTA CER FEM HD 32/+3MM T1
• Common Device Name: HIP PROSTHESIS
• 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: 21713741
• Report Number: 3002806535-2025-00129
• Device Sequence Number: 18660035
• Product Code: LZO
• UDI-Device Identifier: 00887868271557
• UDI-Public: (01)00887868271557(17)341011(10)3217105
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K200959
• 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): 09/19/2025

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: 650-1161
• Device Lot Number: 3217105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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 Sex: Unknown