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

Catalog Number	650-0662
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: g7 neutral e1 liner 36mm f; item# 010000858; lot# 3559351 g7 bonemaster ltd acet shl 54f; item# 010000704; lot# 3578463 sirius hip stem 44-d; item# 51-199341; lot# 882080 sirius winged centralizer; item# 51-199300; lot# unknown g2 - foreign: united kingdom 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 eight years post right total hip arthroplasty, the patient underwent a closed reduction due to a dislocation following a fall.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Clinical review forms were provided and reviewed by a health care professional.The review identified the following: 6-months post-op: patient reports no pain or difficulties with adl¿s.1-year post-op patient reports some difficulties with walking about, uses a cane most of the time.No pain or difficulties with adl¿s.Rom flexion 90°, abduction 10°, adduction 30°.Negative trendelenburg sign.3-year post-op: patient reports some difficulties with walking about, uses a cane for long walks.No pain, no difficulties with adl¿s.Flexion 90° abduction 10°, adduction 30°.Negative trendelenburg sign.5-year post-op phone interview: patient reports doing well with device.8 years post op; right hip dislocation closed reduction: right hip dislocation.Reported patient fell over and hip dislocated.Unsuccessful reduction attempted.Closed reduction of dislocated total prosthetic replacement.Discharged the following day.Radiographs were received but not submitted to a radiologist for assessment as the image files are dated 3 years and 3 months post initial op and therefore do not correlate to any allegations including the event of dislocation post-fall 2 months ago.With the available information, a definitive root cause could not be determined however it was reported that the patient tripped while playing with his dog and twisted his right leg which might have been a contributing factor.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 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: 18873334
• Report Number: 3002806535-2024-00086
• Device Sequence Number: 7786463
• Product Code: LZO
• UDI-Device Identifier: 00887868271182
• UDI-Public: (01)00887868271182(17)240531(10)3340521
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 650-0662
• Device Lot Number: 3340521
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2014
• 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 H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 77 KG