MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DUAL MOBILITY VIVACIT-E HIGHLY CROSSLINKED BEARING; PROSTHESIS, HIP

Model Number	N/A
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).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and review identified the following: despite lengthening significantly through the new ceramic head the patient dislocated and had dissociation of the 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.Medical timeline: initial total hip arthroplasty and revised twelve years later due to metal related pathology and elevated metal ion levels.Revision one month later due to dislocation and instability.A definitive root cause cannot be determined.The complaint is confirmed based on the medical records.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 information is available at the time of this report.
Event or Problem Description
It was reported that approximately 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
(b)(4).D10: cat# 650-1055 lot# 3123214 cer bioloxd option hd 28mm.Cat# 15-103203 lot# 500820 taperloc microp lat fmrl 9.0mm.Cat# us157850 lot# 702030 m2a-magnum pf cup 50odx44id.Cat# 139252 lot# 326930 m2a-magnum 42-50mm tpr insrt-6 0/-6mmt1.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: DUAL MOBILITY VIVACIT-E HIGHLY CROSSLINKED BEARING
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19566991
• Report Number: 0001822565-2024-02052
• Device Sequence Number: 15001856
• Product Code: LPH
• UDI-Device Identifier: 00889024572706
• UDI-Public: (01)00889024572706(17)280304(10)65817810
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031012
• Device Lot Number: 65817810
• 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: 08/13/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female