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

Device Problem Insufficient Information (3190)

Patient Problem Synovitis (2094)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(4).

Event Description

It is reported in a journal article that six patients experienced recurrent synovitis 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.Upon additional information received for the reported event from the journal article author, it was discovered that the six patients who experienced synovitis post-operatively were published in error under the wrong article.This incident was additionally published under "arthroscopic synovectomy for the rheumatoid elbow (short-term outcome)." orthopaedic, fsbi research institute of rheumatology.72:a892.3-a892.This event is determined to not be reportable as there is no allegation against zimmer biomet product.

• Brand Name: UNKNOWN COONRAD-MORREY IMPLANT
• 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: 6333195
• MDR Text Key: 67533737
• Report Number: 0001822565-2017-00727
• 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
• Report Date: 02/08/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2017
• 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