MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CERAMIC OPTION HD 32MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	650-1056
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D-10 650-1163, delta cer fem hd 32/ 3mm t1, lot 3134710.650-1068, cer option type 1 tpr sleve +6, lot 3197579.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that during a hip revision procedure, the sterile package labeled for a 32 mm modular ceramic head with an option sleeve (+6) was opened and the mismatch between the labeled contents and the actual device was identified.The package contained a nonmodular 32 mm ceramic head (-3).Obtaining a correct replacement caused a delay of approximately 15 minutes.There were no consequences or impact to the patient.Attempts have been made and no further information has been provided.

• Brand Name: BIOLOX DELTA CERAMIC OPTION HD 32MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• 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: 25039465
• Report Number: 3002806535-2026-00175
• Device Sequence Number: 21254902
• Product Code: LZO
• UDI-Device Identifier: 00887868271380
• UDI-Public: (01)00887868271380(17)321003(10)3123244
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: 650-1056
• Device Lot Number: 3123244
• 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: 04/05/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2022
• 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: Female