MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER IMPACTOR 36 MM; PROSTHESIS, SHOULDER

Catalog Number 00430902900

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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.

Event Description

It was reported by the sales rep that version setting piece for impactor broke off during reverse left total shoulder arthroplasty procedure.There was no impact to the patient.No further information has been provided at the time of this report.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the post on the impactor was fractured and the fractured portion was not returned.Hardness test was performed and was within specifications.The device has a potential field age of 10 years.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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 additional event information is available at the time of this report.

• Brand Name: LINER IMPACTOR 36 MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8811628
• MDR Text Key: 151727529
• Report Number: 0001822565-2019-03125
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00430902900
• Device Lot Number: 61150170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1