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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d10, g3, g6, h2, h3, h6, h11.D10: item # 51-116160, tprlc 133 mp type1 bm so 16.0, lot # 7560160.Item # 010000937, g7 hi-wall e1 liner 36mm g, lot # 7554411.The products involved in the reported event were not returned for investigation; however, a picture was provided and reviewed which showed an explanted head and stem.There appears metal transfer to the head which may indicate a dislocation however this may also have been caused upon removal.The reported dislocation cannot be confirmed from the photograph.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/s.One undated radiographs was provided and reviewed by a radiologist.The review identified a right total hip arthroplasty without definite hardware failure or loosening and no horizonal offset deficiency.Based on the available information, the reported dislocation due to horizonal offset deficiency cannot be confirmed however it is clear that the devices have been revised.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 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.
Additional Manufacturer Narrative
(b)(6): d10: item # 51-116160, tprlc 133 mp type1 bm so 16.0, lot # 7560160.Item # unknown, unknown liner, lot # unknown.G2: report source australia.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 a primary hip arthroplasty.Subsequently, the patient was revised nearly one (1) month post implantation due to dislocation due to horizontal offset deficiency.The stem and head were explanted.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: DELTA CERAMIC FEM HD 36/0MM
• Common Device Name: PROSTHESIS, HIPS
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20785215
• Report Number: 3002806535-2024-00437
• Device Sequence Number: 13020035
• Product Code: LPH
• UDI-Device Identifier: 00887868271175
• UDI-Public: (01)00887868271175(17)330106(10)3140471
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 02/20/2025

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 Model Number: N/A
• Device Catalogue Number: 650-0661
• Device Lot Number: 3140471
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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; SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 110 KG