MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 17MM STD; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Will be returned.

Event Description

It was reported the comprehensive stem size primary stem packaging was broken, the plastic was cracked through to the inside packing containing the stem.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

Cmp-(b)(4).Reported event was confirmed as visual inspection of the returned product found the outer box has some damage.The outer blister is cracked.The inner blister is not damaged.The sterility, or breach thereof, cannot be determined as the sterile packaging was returned opened.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.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 available at the time of this report.

• Brand Name: COMP PRIMARY STEM 17MM STD
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11768938
• MDR Text Key: 248812721
• Report Number: 0001825034-2021-01360
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304470743
• UDI-Public: (01)00880304470743(17)290421(10)732270
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113657
• Device Lot Number: 732270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1