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

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

Roskidaylo et al."total elbow replacement coonrad-morrey in patients with rheumatoid arthritis." orthopaedic, fsbi research institute of rheumatology.72:a892.3-a892.No device or photos were received; therefore the condition of the device is unknown.Device history records cannot be reviewed since the lot number is unknown.This device is used for treatment.Product history search cannot be completed since the lot number is unknown.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definite root cause cannot be determined with the information provided.The article was written by a roskidaylo, a logunov, s makarov and v amirdjanova.

Event Description

It is reported in a journal article that two patients experienced ulnar nerve palsy and/or neurapraxia following elbow arthroplasty.No further information is available.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This information received does not change the investigation previously reported as the information provided cannot be confirmed to have caused the post-operative complications in the two patients initially reported.

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.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.X-rays were reviewed, and the reviewer stated, "no obvious abnormal finding seen radiographically to account for ulnar nerve palsy.It is common in the postoperative state to have scarring within the cubital tunnel which may lead to palsy." device history record (dhr) review and complaint history review was unable to be performed as product identification 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.

• Brand Name: UNKNOWN COONRAD-MORREY ULNAR COMPONENT
• Type of Device: ELBOW PROSTHESIS
• 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: 6333209
• MDR Text Key: 67533136
• Report Number: 0001822565-2017-00729
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: PN/A
• 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,Followup,Followup,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other