MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP CEMENT FMRL HD RESUR 50M; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Torn Material (3024)

Patient Problem Toxicity (2333)

Event Type  Injury  

Event Description

As part of a retrospective clinical study, a patient was identified who underwent a right hip recap procedure on (b)(6) 2006.Subsequently, patient experienced a gluteus medius tear and elevated metal ion levels.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 related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "elevated metal ion levels have been reported with metal-on-metal articulating surfaces." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-08602 / 08603).

• Brand Name: RECAP CEMENT FMRL HD RESUR 50M
• 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: 4249960
• MDR Text Key: 20751814
• Report Number: 0001825034-2014-08602
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK021799
• 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
• 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: 11/30/2016
• Device Model Number: N/A
• Device Catalogue Number: US157250
• Device Lot Number: 505560
• 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: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 74