MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR/SRS IM HUMERAL CLAMP; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign country: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Patient not yet revised.

Event Description

It has been reported that patient had a custom total humeral and shoulder replacement.Subsequently, the patient is experiencing possible linkage/stability issues with the connection of the total humeral device.No additional patient consequences were reported.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: COMPR/SRS IM HUMERAL CLAMP
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8196585
• MDR Text Key: 131409978
• Report Number: 0001825034-2018-11527
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: CUSTOM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP0000385
• Device Lot Number: 826520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 82