MAUDE Adverse Event Report: ZIMMER, INC. NEXEL PLASMA SPRAYED ULNAR COMPONENT SIZE 6 115MM LENGTH RIGHT; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Difficult To Position (1467); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.This report is number 1 of 2 mdrs filed for the same patient (reference(b)(4).

Event Description

It was reported that during right elbow arthroplasty, the long ulnar component didn¿t fit into the medullary cavity and punctured the patient¿s ulna.The surgeon attempted to bend the ulnar component, but alternatively decided to use a shorter ulnar component to complete the procedure.No additional patient consequences were reported.Attempts have been made to retrieve additional information, but no further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed as the lot number of device involved in the incident is unknown.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no trends were identified.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: NEXEL PLASMA SPRAYED ULNAR COMPONENT SIZE 6 115MM LENGTH RIGHT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6657869
• MDR Text Key: 78099324
• Report Number: 0001822565-2017-04349
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00840002611
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention