MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM 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 Code	Joint Dislocation (2374)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 650-1055 ¿ biolox ceramic head ¿ 2964312, 650-1067 ¿ biolox ceramic sleeve ¿ 3031111, 110024465 ¿ dual mobility liner - 976770, unknown cup ¿ unknown part and lot, unknown stem ¿ unknown part and lot.Customer has indicated that the product in process of being returned to zimmer biomet for the investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent a hip revision after an unknown amount of time post implantation.Approximately 1 week later, the patient presented to the er with a dislocated hip.During relocation it was noticed that the outer bearing had dissociated from the inner head and the patient underwent a revision procedure the next day.The head, liner, bearing and sleeve were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected; updated: g4; h2; h3; h6.Reported event was confirmed by review of x-rays provided noting superior dislocation of the femoral component of a left total hip arthroplasty.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.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 event information available at the time of this report.

• Brand Name: VIVACIT-E DM BEARING
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10460647
• Report Number: 0001822565-2020-03072
• Device Sequence Number: 19382980
• Product Code: LPH
• UDI-Device Identifier: 00889024572713
• UDI-Public: (01)00889024572713
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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 Expiration Date: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 110031013
• Device Lot Number: 64689634
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention