MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLY LINER PLUS 3 MM OFFSET 40 MM DIAMETER; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2019

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.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 that during a reverse shoulder revision while inserting the liner, it was properly lined up the humeral spacer and impacted.However, the liner was not seating properly, it was not flush against the spacer.The surgeon showed the gap by fitting a thick blade in between.The surgeon then attempted to impact further and still was not able to seat the liner flush against the spacer.The liner was removed and a new liner was impacted, which fully seated flush against the spacer with no gap in between.No impact to the patient or surgery was noted.

Manufacturer Narrative

(b)(4).Updated: b4, b5, g4, h1, h2, h3, h6, and h10 reported event was considered confirmed as the visual examination showed a heavy indentation near the anti-rotational slot consistent with impacting the liner to the spacer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 further event information available at the time of this report.

• Brand Name: POLY LINER PLUS 3 MM OFFSET 40 MM DIAMETER
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9622043
• MDR Text Key: 186531206
• Report Number: 0001822565-2020-00246
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 00889024269149
• UDI-Public: (01)00889024269149
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• 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: 00434904003
• Device Lot Number: 63733985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1