MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS 60MM DST HML BDY RT; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 211261, compr srs mod stem - 9x200mm, 457560, 211226, compr srs ic seg - 90mm, 409790, unknown ulna component , unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03885.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [remains implanted].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient's right elbow is indicated for revision three (3) years post implantation in order to decrease soft tissue compromise at the ulna/humeral junction.No further information has been provided.The plan is to revise the connector between ulna and humeral complement.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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.

Event Description

It was reported that the patient's right elbow was revised three (3) years post-implantation in order to decrease soft tissue compromise at the ulna/humeral junction.No further information has been provided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Device code - phx.Udi:(b)(4).Concomitant medical products : behning rt nxl ulna 125mm seg part#cp0000892 lot#541180.

• Brand Name: COMPR SRS 60MM DST HML BDY RT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8950034
• MDR Text Key: 156115501
• Report Number: 0001825034-2019-03865
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K173411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• 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: 110029939
• Device Lot Number: 637220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2020
• 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