MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP CEMENT FMRL HD RESUR46MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Complaint, Ill-Defined (2331); Toxicity (2333)

Event Type  Injury  

Event Description

It was reported that a patient enrolled in a clinical study underwent a left femoral resurfacing procedure on (b)(6) 2005.It was further reported that patient experienced metallosis and elevated metal ion levels.No revision procedure has been reported 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: "elevated metal ion levels have been reported with metal-on-metal articulating surfaces." and "material sensitivity reactions." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-00829 / 00830).

Manufacturer Narrative

This follow-up report is being filed to relay this report is a duplicate of 1825034-2015-00818.

Manufacturer Narrative

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

• Brand Name: RECAP CEMENT FMRL HD RESUR46MM
• 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: 4576808
• MDR Text Key: 5551528
• Report Number: 0001825034-2015-00829
• 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,Followup,Followup
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 157246
• Device Lot Number: 222660
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2004
• 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 Weight: 104