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

Catalog Number 32810502704

Device Problems Break (1069); Fracture (1260); Naturally Worn (2988)

Patient Problems Reaction (2414); No Code Available (3191)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised due to an implant failure.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch as well as corrected information.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.Surgical notes were not provided; 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.This report is number 2 of 2 mdrs filed for the same patient (reference 0001822565-2016-04029).

Event Description

Patient underwent an elbow arthoplasty revision procedure approximately five years post-implantation due to pin fracture, bushing wear, and metallosis with onset approximately four years post-operatively.The patient was placed in a cast for eight months prior to revision.The humeral and ulnar components remained implanted following revision.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Further investigation confirmed that the humeral pin is packaged with the coonrad/morrey total elbow interchangeable humeral assembly, sharing the same product identification.The previous medwatch 3500a report submitted under this mfr number reported an unknown humeral pin incorrectly.The complaint sample was evaluated through device history record review and an x-ray review and the reported event was confirmed.An x-ray report confirmed failure of locking pin and disassociation of locking pin.The report stated, "bone mineral density appears normal and there is no evidence of acute fracture or osteolysis.However, there are marked pre-existing bony deformities distal humerus, proximal ulna and proximal radius including absence of distal humeral metaphysis/condyles and absence of proximal ulna and radius.Pre-existing marked bony deformities, as well as young patient age, increase risk of bushing wear and locking pin failure.As far as can be visualized, the humeral stem is grossly midline within the humeral canal.The tip of the ulnar stem is only slightly off-center.Implant placement is unlikely a contributing factor to the reported event." the device history records were reviewed and no discrepancies were found.A review of the complaint history determined that no further action is required, as no trends were identified.A definite root cause was unable to be determined.

• Brand Name: COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY
• 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: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6070602
• MDR Text Key: 58918064
• Report Number: 0001822565-2016-04030
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: PK001989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 32810502704
• Device Lot Number: 61454861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 29 YR
• Patient Weight: 70