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

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 07/31/2020

Event Type  malfunction  

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 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
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10453171
• MDR Text Key: 204337562
• Report Number: 0001822565-2020-03001
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024572676
• UDI-Public: (01)00889024572676(17)250531(10)64755636
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1