MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN COONRAD-MORREY ULNAR COMPONENT; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Roskidaylo et al."total elbow replacement coonrad-morrey in patients with rheumatoid arthritis." orthopaedic, fsbi research institute of rheumatology.72:a892.3-a892.Reference attached journal article.The reported event was unable to be confirmed due to limited information received from the customer.A device history records review was unable to be performed as the lot number of the device involved in the event is unknown.A product history search was unable to be completed as the part and lot number are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Date implanted - pre-operative x-rays were received dated (b)(6) 2011, which indicate that the patient was implanted on or after (b)(6) 2011.Initial reporter - the article was written by a roskidaylo, a logunov, s makarov and v amirdjanova.

Event Description

It is reported in a journal article that one patient experienced ulnar nerve palsy and/or neurapraxia following right elbow arthroplasty.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN COONRAD-MORREY ULNAR COMPONENT
• 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: 6473470
• MDR Text Key: 72173895
• Report Number: 0001822565-2017-01898
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2017

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 04/07/2017
• 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): Other