MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE ULNAR ASSEMBLY PLASMA SPRAYED EXTRA SMALL RIGHT 3 INCH LENGTH; PROSTHESIS, EXTREMITIES

Catalog Number 32810504302

Device Problems Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Reaction (2414); No Information (3190)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02628.Concomitant medical products: part# 32810502704; lot# 61923508.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is unavailable by hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported that patient underwent total elbow arthroplasty approximately eight (8) years ago.Subsequently, devices were removed approximately two (2) months ago.Surgeon classified the failure as mechanical due to overworking the prescribed usage of the implanted total elbow.The implants portrayed loosening and some metallosis, secondary to the patients misuse of their total elbow.Patient was reimplanted approximately one (1) month later with no issues.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.It was reported the failure occurred due to overworking of prescribed usage of elbow.However, without medical records 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: INTERCHANGEABLE ULNAR ASSEMBLY PLASMA SPRAYED EXTRA SMALL RIGHT 3 INCH LENGTH
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10301329
• MDR Text Key: 199660602
• Report Number: 0001822565-2020-02629
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K053189
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 32810504302
• Device Lot Number: 62063679
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10.
• Patient Outcome(s): Hospitalization; Required Intervention