MAUDE Adverse Event Report: ZIMMER, INC. VIVACIT-E®; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	110031013
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a bilateral total hip arthroplasty (tha) done a few years back and had done well.Patient, subsequently, had an extensive lumbosacral fusion, after which point the patient dislocating total hip replacement anteriorly.Ct scans and engineers with the corin group optimized positioning system (ops) analyzed patient's hips in the sitting and standing position and gave recommendations for the ideal location of the acetabular component.Surgical/clinical staff then went ahead and did that acetabular revision approximately eight weeks ago.Patient had done well and at her six-week postoperative visit, patient expressed absolutely no pain and everything was doing very, very well.About one week ago, something happened and patient dislocated her hip.There was some concern that there may have been more going on than what the patient said initially.However, she said that she flexed her hip past 90 degrees in the shower, rotated internally and then adducted her femur.This caused the first dislocation.Over one week she had two subsequent dislocations.Because of this, we decided to do a revision.Description of catastrophic failure of the dual mobility construct: after the fascia was opened, surgical team found the polyethylene large ball sitting in the soft tissues independent of the oxinium femoral head, which was still affixed superiorly to the trunnion.The representative in the room was asked what the reported incidence of this was and he was aware that there had been one reported incidence of this.
Event or Problem Description
The patient had a bilateral total hip arthroplasty (tha) done a few years back and had done well.Patient, subsequently, had an extensive lumbosacral fusion, after which point the patient dislocating total hip replacement anteriorly.Ct scans and engineers with the corin group optimized positioning system (ops) analyzed patient's hips in the sitting and standing position and gave recommendations for the ideal location of the acetabular component.Surgical/clinical staff then went ahead and did that acetabular revision approximately eight weeks ago.Patient had done well and at her six-week postoperative visit, patient expressed absolutely no pain and everything was doing very, very well.About one week ago, something happened and patient dislocated her hip.There was some concern that there may have been more going on than what the patient said initially.However, she said that she flexed her hip past 90 degrees in the shower, rotated internally and then adducted her femur.This caused the first dislocation.Over one week she had two subsequent dislocations.Because of this, we decided to do a revision.Description of catastrophic failure of the dual mobility construct: after the fascia was opened, surgical team found the polyethylene large ball sitting in the soft tissues independent of the oxinium femoral head, which was still affixed superiorly to the trunnion.The representative in the room was asked what the reported incidence of this was and he was aware that there had been one reported incidence of this.

• Brand Name: VIVACIT-E®
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): ZIMMER, INC.; 56 east bell drive; warsaw IN 46581
• MDR Report Key: 14605118
• Report Number: 14605118
• Device Sequence Number: 6085529
• Product Code: LPH
• UDI-Device Identifier: 00889024572713
• UDI-Public: (01)00889024572713(17)250331(10)64689534
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2022
• Report Date (Section F): 05/29/2022

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
• Device Model Number: 110031013
• Device Catalogue Number: 110031013
• Device Lot Number: 64689634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 06/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White
• Date Report Sent to FDA: 05/29/2022