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

Catalog Number	650-0660
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10 - associated medical devices: 0 degree face angle 36mm i.D.Cemented revision shell liner; item# 00710505836; lot# 65515563 arcos con sz c std 60mm; item# 11-301303; lot# 65698547 arcos 20x150mm spl tpr dist; item# 11-300820; lot# 313970 bone screw self-tapping 40 mm length 6.5 mm dia; item# 00662406540; lot# 65655248 g2 - foreign: 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 approximately two months and two weeks post implantation, the patient underwent a revision due to hip dislocation.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided picture identified the cone body and head still assembled and containing bio debris.Further evaluation could not be performed based on the provided image.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.Radiographs were provided and reviewed by a radiologist.Review of the available records identified the following: on the images submitted, implant fit appears maintained.There is a dislocation on the spot view.Bone quality is osteopenic.The acetabular cup abduction angle measures approximately 52 degrees.There is no loosening or abnormal radiolucency.There is malalignment with dislocation on the spot ap view.The dislocation is confirmed.No implant malposition is noted but the cup anteversion cannot be measured on these images.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/-3MM
• Common Device Name: HIP PROSTHESIS
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19556432
• Report Number: 3002806535-2024-00225
• Device Sequence Number: 15136087
• Product Code: LZO
• UDI-Device Identifier: 00887868271168
• UDI-Public: (01)00887868271168(17)331212(10)3185359
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200959
• 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): 09/26/2024

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: 650-0660
• Device Lot Number: 3185359
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male