MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CERAMIC FEM HD 36/+3MM; HIP PROSTHESIS

Catalog Number	650-0662
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure, the surgeon fitted the ceramic femoral head onto the stem cone and, upon impaction, the ceramic head fractured with a single blow.The surgeon carefully removed the broken head along with several fragments using both hands.The procedure was completed using an alternative implant without further complications.Due diligence is still in progress for this complaint; no further additional information or product has been received.
Additional Manufacturer Narrative
(b)(4) d10 - associated medical devices: tprlc 133 fp type1 pps so 12.0; item# 5110012033; lot# j7533274, g7 pps ltd acet shell 58g; item# 010000666; lot# 7690199, g7 longevity high wall 36mm g; item# 20123607; lot# 66163961, g7 screw 6.5mm x 35mm; item# 010001000; lot# 7720639.G2 - foreign: brazil.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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.Product was evaluated by the supplier.It was identified that the density of the femoral head complied with the material specification for biolox delta components.The microstructure as obtained from the quality documents meets the requirements specified at the time of production, too.There is no indication of any pre-existing material defect.Secondary metal transfer patterns can be located on the fragments of the femoral head, as a result of contact with metal parts and/or surgical instruments.Primary metal transfer on the bore of the femoral head can be found as a narrow circumferential stripe of intense nearly black colour.A second circumferential line of metal transfer can be found on the bore.The measure distance between the proximal and distal lines of metal could match with the length of a stem taper.The pattern of the two lines on the bore could indicate a contact of a head and stem taper at the proximal and the distal stem taper end.However, it cannot be conclusively determined whether this second circumferential line of metal transfer occurred prior to or after the primary fracture event.The primary fracture surfaces and the region of fracture origin can be identified.Due to secondary chip-offs the fracture origin cannot be identified.Material analysis of the metal transfer positions revealed titanium as the dominant element, indicating that these metal transfer patterns were generated by the metal stem used.Based on the provided fragments, no conclusion can be drawn regarding a possible cause for the fracture of the femoral head.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.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 CERAMIC FEM HD 36/+3MM
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22493222
• Report Number: 3002806535-2025-00264
• Device Sequence Number: 17202202
• Product Code: LZO
• UDI-Device Identifier: 00887868271182
• UDI-Public: (01)00887868271182(17)341129(10)3219040
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 650-0662
• Device Lot Number: 3219040
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• 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.
• Patient Sex: Unknown