MAUDE Adverse Event Report: ZIMMER, INC. COONRAD/MORREY INTERCHANGEABLE ULNAR ASSEMBLY; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Fracture, Arm (2351)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Implant date was in 2010.Customer has indicated that the product might be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the patient underwent right total elbow surgery on an unknown date.Approximately 7 years later, the patient is indicated for revision due to ulnar component fracture and bone fracture during day-to-day tasks.A custom implant has been requested to perform the revision.No revision has been reported to date, and no other serious injury is reported.No further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint was confirmed through review of radiographs.There are warnings in the package insert that this type of event can occur and associate risks are addressed in risk documentation.Device history report was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause of the event could not e 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.

• Brand Name: COONRAD/MORREY INTERCHANGEABLE ULNAR ASSEMBLY
• 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: 6477066
• MDR Text Key: 72270678
• Report Number: 0001822565-2017-02134
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK001989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 32810509302
• Device Lot Number: 62859963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: 08/17/2017
• Supplement Dates FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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
• Treatment: UNKNOWN CEMENT CAT#: NI LOT#: NI
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 52