MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ROTATING HINGE KNEE FEMORAL; KNEE PROSTHESIS

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 05/13/2015

Event Type  Injury  

Event Description

It is reported that patient was revised due to broken hinge mechanism on the femoral component.The tibial component was also revised due to possible loosening.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Device history records could not be reviewed as the part and lot numbers are unknown.This device is used for treatment.In the returned x-rays it appears as though there is a piece of debris distal to the femoral component.It was reported that the tibial component was revised for loosening and once the knee was opened it was seen that the portion of the hinge that holds the hinge mechanism to the femoral component fractured and the broken parts were removed or replaced.The package insert states that "because the rotating hinge knee is a highly constrained device, the risk of component breakage, loosening and polyethylene wear may be greater than for less constrained knee implants".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 definitive root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN ROTATING HINGE KNEE FEMORAL
• Type of Device: KNEE 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: 4861491
• MDR Text Key: 5812691
• Report Number: 1822565-2015-00942
• Device Sequence Number: 1
• Product Code: HRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2015
• 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
• Treatment: LOT# UNKNOWN, QUANTITY: 2; UNKNOWN ZIMMER AUGMENT BLOCK, CAT# UNKNOWN,; CAT# UNKNOWN, LOT# UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR