MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BEHNING RT NXL ULNA 125MM SEG; 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: 211254, compr srs 60mm dst hml bdy rt, 366310; 211261, compr srs mod stem - 9x200mm, 457560; 211226, compr srs ic seg - 90mm, 409790.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03865.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [remains implanted].The investigation is in process, 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

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi: (b)(4).Concomitant medical products : compr srs 60mm dst hml bdy rt part#110029939 lot#637220.

Event Description

No further event information at the time of this report.

• Brand Name: BEHNING RT NXL ULNA 125MM SEG
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8950038
• MDR Text Key: 156130309
• Report Number: 0001825034-2019-03885
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: CP0000892
• Device Lot Number: 541180
• 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
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention