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 Information (3190)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint sample was evaluated and the reported event was confirmed.Supplied photos show outer and inner packaging that reflect 38mm size and one of product with calipers showing 42mm.Returned product- one vivacit-e dm liner 28 x 38mm was returned and evaluated.Upon visual inspection the ceramic head was installed inside of the returned liner.Dimensional analysis was done on the height and width and was found out of conformance of the print per the 38mm tabulated drawing measurements.When compared to the 42mm measurements they would be conforming.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to a manufacturing deficiency.The issue is being farther investigated through the capa process.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 during an initial hip arthroplasty the dual mobility bearing was opened and combined with a 28mm head.Surgeon attempted to reduce but the bearing was too large.Implant was looked at closely and appeared larger than the packaged 38mm.When comparing the trial to the implant the implant was much larger.A new 38mm bearing was opened, appeared to be the correct size and implanted.There was a 3 ¿ 5 min delay in surgery.No additional information.

• 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: 10453171
• Report Number: 0001822565-2020-03001
• Device Sequence Number: 3394568
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/26/2020
• 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