MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK HUMERAL; PROSTHESIS, EXTREMITIES

Catalog Number UNK HUMERAL

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

Patient Problem Ossification (1428)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Literature title - long-term outcomes of total elbow arthroplasty for distal humeral fracture: results from a prior randomized clinical trial.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01963.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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.[(b)(4)].

Event Description

On approximately three (3) weeks ago, a journal article was retrieved from journal of shoulder and elbow surgery (2019) that reported a randomized controlled trial study from 2000-2006 in the usa that looked at long-term outcomes of total elbow arthroplasty (tea) for distal humeral fracture.The purpose of the study was to examine long-term outcomes and survivorship of semiconstrained tea performed for acute trauma compared with patients having undergone orif.The study reported one patient underwent resection for heterotopic ossification at 4 months postoperatively.

Event Description

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

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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: UNK HUMERAL
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10119219
• MDR Text Key: 194132320
• Report Number: 0001822565-2020-01995
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HUMERAL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2020
• 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