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

Catalog Number	650-0661
Medical Device Problem Codes	Malposition of Device (2616); Noise, Audible (3273)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10 - associated medical devices: 58mm o.D.Size ll porous uncemented with cluster holes shell; item# 00875705801; lot# 63640013 bone screw self-tapping 6.5 mm dia.30 mm length; item# 00625006530; lot# 63535924 bone screw self-tapping 6.5 mm dia.40 mm length; item# 00625006540; lot# 63214016 arcos 16x150mm spl tpr dist; item# 11-300816; lot# 124690 arcos con sz d std 60mm; item# 11-301304; lot# 213170 biolox delta ceramic taper liner, size ll / 36 i.D; 00877501336; lot# 2738375 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 the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately six years and six months later due to poor alignment of the acetabular component.There was reproducible audible squeaking and crepitus by the patient.It was indicated that no further information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Visual examination of the provided pictures identified a ceramic head with what appears to be metal transfer marks on the articulating surface.It is likely that the marks were caused upon removal of the head during revision surgery as the picture of the mating ceramic liner does not have a corresponding metal transfer pattern.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.One x-ray picture was provided and reviewed by a radiologist.Assessment of imaging: right hip arthroplasty components are anatomically aligned.There is no acute osseous abnormality.The device has not been returned therefore the condition of the component remains unknown.Patient factors that may have affected the performance of the components such as activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.If and to what extent other possible factors might have been involved also remains unknown.With the available information, 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 36/0MM
• 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: 19581875
• Report Number: 3002806535-2024-00228
• Device Sequence Number: 7326810
• Product Code: LZO
• UDI-Device Identifier: 00887868271175
• UDI-Public: (01)00887868271175(17)270501(10)2017050061
• 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: 2017
• 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): 08/23/2024

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: 650-0661
• Device Lot Number: 2017050061
• 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: 05/27/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2017
• 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