MAUDE Adverse Event Report: ZIMMER INC UNKNOWN COONRAD/MORREY ULNAR STEM ASSEMBLY; ELBOW PROSTHESIS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.Please reference literature at the following location: http://www.Sciencedirect.Com/science/article/pii/s1058274606000851 (b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to prolonged wound drainage and c-ring disassociation.

Manufacturer Narrative

No devices or photos were received; therefore the condition of the components is unknown.Device history records cannot be reviewed since the part and lot numbers are unknown.These devices are used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.It is noted from the article that ¿the c-ring had not been fully engaged.It dislocated and required revision 6 weeks after the index procedure.¿ it was also noted in the article that during the revision surgery aseptic, prolonged wound drainage was also performed.Product history search cannot be completed and compatibility cannot be verified since the part and lot numbers are unknown.Patient activity level and adherence to rehabilitation protocol is unknown.In 1998, the coonrad-morrey c-ring locking mechanism was replaced by a pin-within-pin fixation.The article also states that ¿the currently available coonrad-morrey total elbow device uses pin-within-pin fixation for coupling the humeral and ulnar components instead of the c-ring mechanism that was in use during the period of this study.This modification probably reduces complications with coupling of the implant.¿ a definite root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN COONRAD/MORREY ULNAR STEM ASSEMBLY
• Type of Device: ELBOW PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5486174
• MDR Text Key: 39879649
• Report Number: 1822565-2016-00592
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2016
• 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
• Patient Age: 77 YR