MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP +6 41MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device product code: phx.(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

Product was returned with packaging damage and sterility barrier was compromised.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d4; g4; g7; h1; h2; h3; h4; h6.Visual inspection of the returned product found the outer carton and sterile packaging have been damaged.Sterility has been compromised.Visual inspection of the returned product found the outer carton and sterile packaging have been damaged.Sterility has been compromised.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.Complaint sample was evaluated and the reported event was confirmed.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 RVRS SHLDR GLNSP +6 41MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10233008
• MDR Text Key: 198481961
• Report Number: 0001825034-2020-02636
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304475816
• UDI-Public: (01)00880304475816
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 115326
• Device Lot Number: 103710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1