MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP PF FMRL HD RESURF 50MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2010

Event Type  Injury  

Event Description

It was reported that patient enrolled in a (b)(4) study and underwent a right femoral resurfacing procedure on (b)(6) 2008.During post-operative monitoring, a fractured femoral component was noted on (b)(6) 2010.These findings were found due to follow up monitoring, there were no symptoms reported by the patient.There has been no reported revision procedure to date.

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 9 states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.".

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.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 14 states, "intraoperative or postoperative bone fracture of the femoral neck and/or postoperative pain.".

Event Description

It was reported that patient enrolled in a clinical study and underwent a right femoral resurfacing procedure on (b)(6) 2008.During post-operative monitoring, an intertrochanteric fracture after a patient fall was noted on (b)(6) 2010.These findings were found due to follow up monitoring, there were no symptoms reported by the patient.Subsequently, patient was revised on an unknown date.

Manufacturer Narrative

Event description ¿ patient was not enrolled in a clinical study.A retrospective clinical review identified the patient¿s event.

Event Description

As part of a retrospective clinical study, a patient was identified who underwent right femoral resurfacing procedure on (b)(6) 2008.Subsequently, the patient experienced an intertrochanteric fracture after a fall was noted on (b)(6) 2010.The patient was revised on an unknown date.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

As part of a retrospective clinical study, a patient was identified who underwent right femoral resurfacing procedure on (b)(6) 2008.Subsequently, the patient experienced an intertrochanteric fracture after a fall was noted on (b)(6) 2010.The patient was revised on (b)(6) 2010.

• Brand Name: RECAP PF FMRL HD RESURF 50MM
• Type of Device: PROSTHESIS, HIP
• 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: 3938397
• MDR Text Key: 4598318
• Report Number: 0001825034-2014-06212
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK023188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/18/2014

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: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: US157150
• Device Lot Number: 496040
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2014
• Initial Date FDA Received: 07/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/03/2014; 09/23/2014; 11/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2008
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 73