MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLY LINER PLUS 6 MM OFFSET 40 MM DIAMETER; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 00434901213, humeral stem 12 mm stem diameter 130 mm, lot # 64688247.Catalog #: 00430902800, liner impactor 40 mm, lot # unknown.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the poly liner was mis - shaped and would not fit the humeral implant correctly.The surgeon used a drill to remove the excess poly material.Delay was 10 mins to drill away excess poly material.No adverse events have been reported as a result of the malfunction.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.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 6 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: 12011213
• MDR Text Key: 256761560
• Report Number: 0001822565-2021-01661
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00434904006
• Device Lot Number: 62749515
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1