MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 15MM MINI; PROSTHESIS, SHOULDER

Catalog Number 113635

Device Problem Packaging Problem (3007)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

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 that the box was damaged inside making the stem implant unsterile.The stem was not implanted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Visual examination of the returned product packaging/provided picture identified the blister to be damaged.The packaging was returned opened, and photo shows packaging after opening, therefore the sterility of the device cannot be determined.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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: COMP PRIMARY STEM 15MM MINI
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10967860
• MDR Text Key: 220220338
• Report Number: 0001825034-2020-04247
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304462663
• UDI-Public: (01)00880304462663
• Combination Product (y/n): N
• PMA/PMN Number: K060692
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113635
• Device Lot Number: 867500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1