MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-MAGNUM MOD HD SZ 42MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Event Description

Legal counsel for patient reported that the patient underwent a right total hip arthroplasty on (b)(6) 2005.Patient's legal counsel further reported patient was revised on (b)(6) 2006 due to patient allegations of pain.This report is based on allegations set forth in plaintiff¿s notice and the allegations there in are unverified.Additional information received in operative report noted patient underwent a right hip revision procedure on (b)(6) 2006 due to unspecified acetabular complications.Operative report further noted disassociation between the modular head and acetabular cup, reactive tissue and thickened capsular tissue.All components were removed and replaced.Operative report noted patient underwent a left total hip arthroplasty on (b)(6) 2005.

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: "metal on metal articulating surfaces have limited clinical history.Although mechanical testing demonstrates that metal on metal articulating surfaces produce a relatively low amount of particles, the total amount of particulate produced remains undetermined.Elevated metal ion levels have been reported with metal on metal articulating surfaces.Because of the limited clinical and preclinical experience, the long-term biological effects of the particulate and metal ions are unknown." this report is number 5 of 6 mdrs filed for the same event (reference 1825034-2015-00381 & 01859 & 01871 & 01872 & 01904 & 01905).

Manufacturer Narrative

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

• Brand Name: M2A-MAGNUM MOD HD SZ 42MM
• 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: 4750338
• MDR Text Key: 5705187
• Report Number: 0001825034-2015-01904
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK833175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2015
• Device Model Number: N/A
• Device Catalogue Number: 157442
• Device Lot Number: 744340
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2005
• 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