MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION

Model Number 2232-04-18

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event occurred between (b)(6) 2021 and (b)(6) 2022.Concomitant medical products: cmn femoral nail, ccd 130°, left, 㸠10 mm, 34 cm, catalog#: 47249334310, lot#: 3020635.Cmn lag screw, 㸠10.5 mm, 120 mm including set screw, catalog#: 47248512010, lot#: 3042375.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head, catalog#: 47248403550, lot#: 65007883.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head, catalog#: 47248403750, lot#: 64997560.Cephalomedullary nail cap 5 mm height, catalog#: 47248700205, lot#: 64745428.Report source foreign: germany.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a procedure to repair a left, comminuted, subtrochanteric fracture.On an unknown timeframe post-implantation, the connection between the titanium rod of the femur and the screw spindle of the joint head loosened and shifted.The fracture has been unable to heal due to the loosening and constant movements.An additional surgery is pending.Due diligence is in progress for this event; to date no further information has been provided.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided.Images assessed but not sent to mmi for review due to poor photocopy imaging quality.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15459302
• MDR Text Key: 300294771
• Report Number: 0001822565-2022-02729
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 00889024039513
• UDI-Public: (01)00889024039513(17)310308(10)65046164
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2232-04-18
• Device Catalogue Number: 00223200418
• Device Lot Number: 65046164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Sex: Male