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 Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the wrong implant was in the dual mobility active articulation head box during an initial hip arthroplasty.They opened a 38mm size c for a 48 cup and there was a 42mm in the box which goes with a 52mm cup.The device was implanted but detected there was an issue.They used a caliper, after taking the head off and measured it, they saw it was 4mm's bigger than it was supposed to be.They opened another 38mm poly ball e1 active articulation and it was the correct size.No complications or harm for the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.Complaint confirmed.Visual review of the device shows no damage to the liner.Item and lot are not etched on the device and unable to be confirmed.The product identifier for overall height and width were measured and show the device non-conforming to 38mm specification.The dimensions for product identifiers do however fall within specification for a 42mm liner.Radiographs were provided and reviewed by a health care professional.Coob confirmed intra/post op and there are additional complaints for the part and lot combination for same/similar issue.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.The event 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

No additional information on the reported event.

• 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
• MDR Report Key: 10489698
• MDR Text Key: 205697769
• Report Number: 0001822565-2020-03145
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024572676
• UDI-Public: (01)00889024572676
• Combination Product (y/n): N
• PMA/PMN Number: K190656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

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: 09/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1