MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COCR TROCH CABLE 1.6MMX750MM; FIXATION, CERCLAGE

Model Number N/A

Device Problems Break (1069); Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369)

Event Date 06/20/2011

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, ¿nonunion or delayed union which may lead to breakage of the implant.¿ this report is number 4 of 4 mdrs filed for the same event (reference 1825034-2015-04270 / 04273).

Event Description

It was reported that patient underwent an initial right hip arthroplasty on an unknown date.Subsequently, the patient was revised four times, for unknown reasons on unknown dates.The patient was further revised on (b)(6), 2006 due to unknown reasons.Subsequently, patient underwent a revision procedure on (b)(6), 2009 due to dislocation, instability and a greater trochanteric fracture.It was further reported patient underwent a closed reduction procedure on (b)(6), 2011 due to dislocation.Patient underwent a revision procedure on (b)(6), 2011 due to recurrent dislocation and chronic non-union of the greater trochanteric fracture.During the procedure, it was noted the trochanteric claw plate was loose and two of the cables had broken.Patient underwent a hardware removal procedure on (b)(6), 2011 due to fractured trochanteric hardware as a result of patient noncompliance.

• Brand Name: COCR TROCH CABLE 1.6MMX750MM
• Type of Device: FIXATION, CERCLAGE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5144901
• MDR Text Key: 28035962
• Report Number: 0001825034-2015-04273
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK982545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 120003
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2015
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 86