MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP PF FMRL HD RESURF 54MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 12/22/2008

Event Type  Injury  

Event Description

It was reported that patient enrolled in a clinical study underwent a left femoral resurfacing procedure on (b)(6) 2008.During post-operative monitoring, loosening of the acetabular cup was noted on (b)(6) 2008.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.A review of the invoice history confirmed the surgery 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 these types of events can occur: under possible adverse effects, number 4 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.".

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 left femoral resurfacing procedure on (b)(6) 2008.Subsequently, the patient experienced loosening of the acetabular cup, noted on (b)(6) 2008.There has been no reported revision procedure.A review of the invoice history confirmed the surgery date.Additional information received revealed patient's revision surgery performed on (b)(6) 2008 was due to a loose femoral component.

Manufacturer Narrative

This follow-up report is being filed to correct information that was reported in error on the initial report.Corrected event description to state that this report is for femoral component loosening and not acetabular cup loosening as was previously reported.

Event Description

As part of a retrospective clinical study, a patient was identified who underwent a left femoral resurfacing procedure on (b)(6) 2008.Subsequently, the patient experienced femoral component loosening, noted on (b)(6) 2008.Additional information received revealed patient underwent revision surgery on (b)(6) 2008 due to a loose femoral component.

Manufacturer Narrative

Corrected data: 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 left femoral resurfacing procedure on (b)(6) 2008.Subsequently, the patient experienced loosening of the acetabular cup, noted on (b)(6) 2008.There has been no reported revision procedure.A review of the invoice history confirmed the surgery date.

• Brand Name: RECAP PF FMRL HD RESURF 54MM
• 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: 3943399
• MDR Text Key: 4598511
• Report Number: 0001825034-2014-06283
• 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

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: N/A
• Device Catalogue Number: US157154
• Device Lot Number: 462580
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 122