MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 40MM POLY LINER + 3MM 65DEG; PROSTHESIS, SHOULDER

Catalog Number 00434906603

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 12/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Procode: phx.Udi #: (b)(4).Concomitant medical devices: humeral stem 14 mm stem diameter 130 mm stem length cat# 00434901413 lot# 64227538.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00084.

Event Description

It was reported that patient underwent a total shoulder arthroplasty.Approximately 22 months later, the patient underwent a revision due to polyethylene disassociating from the humeral stem.Surgeon states no patient fall or event would have contributed to disassociation.Patient believes it occurred while pulling up his pants.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.Visual examination of the returned product identified: a 40mm poly liner (lot 64004801) was returned for evaluation.As returned, the rim feature, backside, and locking features are damaged.The product information engraving cannot be identified due to damage.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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 is available at the time of this report.

• Brand Name: 40MM POLY LINER + 3MM 65DEG
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11176872
• MDR Text Key: 227002436
• Report Number: 0001822565-2021-00085
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K121543
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00434906603
• Device Lot Number: 64008401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 74