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

Catalog Number	650-0661
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: unknown liner; item# unknown; lot# unknown.G2 - foreign: new zealand.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 five weeks post implantation, the patient bent over and felt a sensation in the hip followed by an audible grinding sound.Subsequent x-rays confirmed a fractured ceramic femoral head.A revision surgery was scheduled to replace the fractured head and liner.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional corrected information.The following sections were updated: b2, b3, b4, b5, d6, d9, d10, g3, g6, h2, h6, h11.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
It was reported that following an initial implantation, the patient experienced a sensation and audible grinding sound in the hip while bending over.Subsequent x-ray analysis confirmed a fractured ceramic femoral head.Approximately two months post implantation, a revision surgery to replace the head and liner was performed.No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional corrected information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.Visual review of the returned ceramic head confirms the device to be fractured and (16) pieces were returned.It is unconfirmed if all pieces were returned.Metal transfer marks are noted in the taper hole and fractured surfaces.No other damage was noted.No dimensional analysis was able to be performed.The product was sent to the manufacturer for further analysis who concluded that the density and microstructure was found to conform to pre-defined specification and that there was no indication of any pre-existing material defect.Secondary metal transfer patterns were confirmed, likely from contact with metal parts and / or surgical instruments.The primary metal transfer on the cone of the head was not as uniformly distributed as would be expected indicating possible contamination during assembly of the head to the stem.Such 'disturbances' can lead to a decrease of the burst strength of the femoral head.The primary fracture surfaces and the region of fracture origin can be identified.A review of the device manufacturing records confirmed no abnormalities or deviations.The delta ceramic femoral head was used in conjunction with a g7 vit e neutral lnr and this combination has been confirmed to be approved/cleared for use and is a legally marketed combination.However, without the details of the associated femoral stem and acetabular cup being provided, the compatibility of the complete implanted system could not be assessed.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.Review of the applicable ifu states under warnings - the femoral stem trunnion and the bore of the ceramic head should be dry and free of contamination prior to assembly, to minimize the risk of crevice corrosion and improper seating.Review of the applicable surgical technique for the stem issue date 2022-04 under femoral head impaction states to thoroughly clean and dry the implant trunnion taper.Disturbances in the metal transfer at the interface between metal stem and femoral head indicates that contamination and debris may have been a contributing factor leading to an increase of mechanical stress which may have led to the fracture of the ceramic femoral head.However, based on 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.

• Brand Name: BIOLOX DELTA CERAMIC FEM HD 36/0MM
• 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: 21908705
• Report Number: 3002806535-2025-00172
• Device Sequence Number: 8728544
• Product Code: LZO
• UDI-Device Identifier: 00887868271175
• UDI-Public: (01)00887868271175(17)340826(10)3211626
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 08/21/2025

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: 650-0661
• Device Lot Number: 3211626
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 08/08/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/22/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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: 56 YR
• Patient Sex: Unknown