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

Model Number N/A

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

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 by the distributor the product arrived damaged with sterility barrier potentially compromised.There was no patient involvement.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the box found damages to the end flaps and side walls.The end flaps are torn and scuffed up.The side walls have creases.Inspection of the inner cavity shows that one corner has been folded over leaving a crease mark.There is also damage to the cavity lid label, it has a partial tear.Review of the device history records identified no related deviations or anomalies.The product was likely conforming when it left zimmer biomet control.Based on the damage observed on the product, it appears that the packaging has been damaged during transit; root cause can be attributed to transit damage.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: COMP PRIMARY STEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8469782
• MDR Text Key: 140508704
• Report Number: 0001825034-2019-01521
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 113640
• Device Lot Number: 726510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1