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

Catalog Number 00223200418

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that a patient's hip was revised due to a displaced fracture of the right greater trochanter.

Manufacturer Narrative

Device history records were reviewed with no deviations or anomalies identified that would have contributed to the reported event.The product was not returned; therefore, the exact condition of the cables is unknown.This device is used for treatment.Patient records were returned for review.Mri right hip notes dated (b)(6) 2016 indicates that there is metal-on-metal right hip total arthroplasty, but there is no periprosthetic fracture at this time.Operative notes dated (b)(6) 2016 indicate that the patient underwent a revision for a failed right total hip arthroplasty due to acetabular component loosening.Pre and post-operative diagnosis does not indicate any kind of fracture.Lack of cupping growth and corrosive debris with large fluid collection and elevated titanium levels were noted in the patient history.All original hip components were explanted, even the well-fixed stem, due to the elevated titanium ion levels noted pre-operatively.Following, new hip components were implanted and achieved equal leg lengths and stability.The hip was then passively abducted 5 degrees in neutral rotation and the osteotomy was contoured internally at its proximal portion, and then closed with two cerclage cables.Small amount of acetabular host bone grafts were obtained from the acetabular reamers and then pressed about the edges of the osteotomy to promote healing.The exact reason for the osteotomy was not indicated within the operative notes.Operative notes dated (b)(6) 2016 indicates that a displaced greater trochanteric fracture was identified.The previously placed zimmer ready cables were cut and removed at this time and the hip was observed to be dislocated posteriorly.Operative notes indicate the fracture was reduced and new cables were assembled.Once fragment rigidity was achieved, the cables were crimped, tensioners were removed, and cables were cut.Excellent stability was noted.The hip underwent full range of motion and all fragments appeared stable.A definitive root cause of the periprosthetic fracture cannot be determined with the information provided.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of x-rays and medical records received.Device history record was reviewed with no deviations identified.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: CABLE-READY CERCLAGE CAGBLE 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: 5823006
• MDR Text Key: 50468345
• Report Number: 0001822565-2016-02319
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• 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: 63258687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 77