MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PAT MAT CNV GLEN COLLINS; EXTREMITIES, IMPLANT

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 113042; lot# 599200; versa-dial 46x18x53 hum head.Item# cp0000235; lot# 236700; compr cnv e1 brg.Foreign: event occurred in (b)(6).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04257.

Event Description

It was reported patient underwent a primary tsr.Subsequently, the patient developed a rotator cuff tear resulting in antero-superior migration of the humeral head resulting in the need for revision surgery to convert to reverse tsr.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.The initial report was forwarded in error and should be voided.

• Brand Name: COMP PAT MAT CNV GLEN COLLINS
• Type of Device: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10938466
• MDR Text Key: 219317227
• Report Number: 0001825034-2020-04258
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304980662
• UDI-Public: (01)00880304980662
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PM0000279
• Device Lot Number: 237880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 87