MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA MODULAR CERAMIC FEM HD 36/-3MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	650-0660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 ¿ 010000702, lot 7817865, g7 shell 50mm.30103604, lot 56747524, 36mm size d neutral liner.G2 ¿ foreign ¿ belgium.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.
Event or Problem Description
It was reported that the patient underwent revision surgery two months post initial left total hip arthroplasty due to polyethylene wear.During the revision subluxation of the insert was noted, the shell, liner, and head were revised without complications.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h11.The following sections were corrected: g1-2.D10 ¿ 51-113140, tprlc 133 type1 bm so 14.0, lot 7234262 the reported product was returned for examination.A visual examination performed revealed dark marks in the taper hole and on the spherical surface from likely metal transfer.No other damage was noted.A dimensional analysis for overall height and overall spherical diameter was performed and found to be in print specification.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.Radiographs were provided and reviewed by a health care professional.Reported event was confirmed by review of medical records.Based on the available information, the reported event can be confirmed.The metallic smearings seen on the articulating surface of the ceramic femoral head are likely due to contact with the cup after the reported unclipping of the pe liner.However, based on the available information, 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 MODULAR CERAMIC FEM HD 36/-3MM
• 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: 21557911
• Report Number: 3002806535-2025-00109
• Device Sequence Number: 4527730
• Product Code: JDI
• UDI-Device Identifier: 00887868271168
• UDI-Public: (01)00887868271168(17)341004(10)3217040
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 650-0660
• Device Lot Number: 3217040
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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