MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM LINER 28 X 38MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed with photos received.Photos show size difference of explanted product to correct revision product.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to a manufacturing deficiency.A corrective action has been initiated for further investigation and root cause determination.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
It was reported that the patient underwent an initial hip arthroplasty.An x ray was taken in post-op, and an abnormality was seen.The doctor decided to re-open the patient and explant the current dual mobility bearing within.After explanation, it was confirmed with calipers that the implanted product was 42mm however the description on the box stated it was a 38mm implant.A new implant was opened and confirmed at 38mm and was implanted into the patient.No further event information available at the time of this report.

• Brand Name: VIVACIT-E DM LINER 28 X 38MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10459118
• Report Number: 0001822565-2020-03029
• Device Sequence Number: 19369866
• Product Code: LPH
• UDI-Device Identifier: 00889024572676
• UDI-Public: (01)00889024572676(17)250531(10)64755636
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/26/2020

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: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 110031009
• Device Lot Number: 64755636
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/27/2020
• 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: UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN STEM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention