MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR METAL IMPACTOR; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

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.

Event Description

It was reported glenosphere impactor was cracked when it was removed it from the reverse pan.There was a versa dial head impactor available, so it did not affect the case.No additional information.

Manufacturer Narrative

(b)(4).Reported event was confirmed per visual examination of the returned product which identified that the tip was fractured.The device shows heavy signs of use.Sem analysis found that the surface artifacts found on the fracture site align with overload fracture.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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 further event information available at the time of this report.

• Brand Name: COMPR METAL IMPACTOR
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11046247
• MDR Text Key: 222685780
• Report Number: 0001825034-2020-04355
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304731516
• UDI-Public: (01)00880304731516(11)181219(10)923330
• Combination Product (y/n): N
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

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 Model Number: N/A
• Device Catalogue Number: 110029132
• Device Lot Number: 923330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1