MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER OPTION HD 28MM; HIP PROSTHESIS

Catalog Number	650-1055
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10 - associated medical devices: cer option type 1 tpr sleve +6; item# 650-1068; lot# 3066240 taperloc microp lat fmrl 9.0mm; item# 15-103203; lot# 500820 28mm i.D.44mm o.D.Size f bearing; item# 110031012; lot# 65817810 m2a-magnum pf cup 50odx44id; item# us157850; lot# 702030 m2a-magnum 42-50mm tpr insrt-6 0/-6mmt1; item# 139252; lot# 326930 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 one month post-implantation, the patient underwent a left hip revision due to a dislocation for unknown reasons and disassociation of the dual mobility with instability upon reduction.The decision was made to revise the patient to a constrained product.The stem was retained.The head and acetabular components were revised.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/or corrected information.The following sections were updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, h11.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.It was confirmed that the ceramic head is compatible with the reported bearing and the cer option type 1 tpr sleve +6.(mating parts).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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: despite lengthening significantly through the new ceramic head the patient dislocated and had dissociation of the patient's dual mobility upon reduction and instability, a decision was made to implant a constrained liner with multiple screws.The femoral component was tested and found to be well-fixed and therefore retained, the trunnion was pristine.The existing acetabular component was removed.After final liner was placed, the locking mechanism was tested and intact.Trial neck and head were put in place and taken through rom, stability was excellent.No evidence of metal wear, poly head of dual mobility in gluteal sling, great press-fit on new acetabulum.No complications.The complaint is confirmed based on the medical records.A definitive root cause cannot be determined.It is unclear from the reported information whether the head became disassociated with the bearing or the bearing became disassociated with the cup.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 CER OPTION HD 28MM
• 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: 19582020
• Report Number: 3002806535-2024-00229
• Device Sequence Number: 11621432
• Product Code: LZO
• UDI-Device Identifier: 00887868271373
• UDI-Public: (01)00887868271373(17)321017(10)3123214
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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: 650-1055
• Device Lot Number: 3123214
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Female