MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISC LT DSTL HMRL BDY SET; PROSTHESIS, ELBOW

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).510k a similar device is cleared under k013042.Concomitant medical products: cp562391 disc lt dstl hmrl bdy set 050970, unknown discovery ulna, unknown articulation kit.The complaint is under investigation.Once the investigation is completed a follow up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01387.

Event Description

It was reported that the patient underwent a total humeral/distal humeral replacement.Subsequently, the patient is being considered for a revision due to disassociation of the linkage between the distal humeral and total humeral components.No additional information is available at this time.

Manufacturer Narrative

The complaint cannot be confirmed as no medical records or x-rays were provided.Review of the device history records identified no deviations or anomalies.Root cause could not be determined.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 additional information is available to report at this time.

• Brand Name: DISC LT DSTL HMRL BDY SET
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8471383
• MDR Text Key: 140586859
• Report Number: 0001825034-2019-01390
• Device Sequence Number: 1
• Product Code: JDC
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• 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: CP562391
• Device Lot Number: 050970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention