MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER CABLE READY CERCLAGE CABLE WITH CRIMP; TRAUMA PROSTHESIS

Catalog Number 00223200418

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is experiencing pain after a hip arthroplasty.

Manufacturer Narrative

This report is being amended to reflect changes.No devices or photos were received, as these remained implanted.Therefore, the condition of the devices is unknown.No deviations or anomalies were noted in the manufacturing process for the lot codes associated with the head, liner, stem, neck, and cable.These devices are used for treatment.The devices were used in an approved and compatible combination.Review of complaint history for the part lot combinations of the reported devices identified no additional complaints.Primary operative notes for procedure performed on (b)(6) 2012 were reviewed.The shell was noted to fully seat with tight press fit obtained.A cerclage wire was applied above the top of the lesser trochanter and tightened down to 100 lbs and crimped to maintain pressure during the procedure.As stated in the notes, the final stem implant was not fully seated.Several mm of porous coating was noted to be exposed proximally.Further attempts to insert it were not made for the fear of a proximal femoral fracture.Once this was fully seated, torque on the insertion handle in both anteversion and retroversion showed no mobility within the femoral canal.On reducing the femoral head, the hip was taken through a full range of motion passively without stiffness.As stated in the notes, the surgeon felt that the overall stability of the hip was felt to be satisfactory.No complications were noted.With the information provided, a specific cause for the reported issue could not be determined with certainty.

• Brand Name: ZIMMER CABLE READY CERCLAGE CABLE WITH CRIMP
• Type of Device: TRAUMA 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5798180
• MDR Text Key: 49650656
• Report Number: 0001822565-2016-02430
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

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: Health Professional
• Device Catalogue Number: 00223200418
• Device Lot Number: 62201545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2012
• 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): Other
• Patient Weight: 92