MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A 38MM MOD HD+6MM NK NO SKRT; PROTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 01/19/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent hip arthroplasty on (b)(6) 2006.Subsequently, patient was revised on (b)(6) 2015 due to adverse reaction to metal debris (armd).The acetabular cup and modular head were removed and replaced with a competitor cup and biomet head.

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 1 states, "material sensitivity reactions." number 6 states, "inadequate range of motion due to improper selection or positioning of components." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." examination of returned device found no evidence of product non-conformance.Dimensional evaluation found component to be within appropriate design specification.During the evaluation, it was noted that there was evidence of subluxation of the joint, scratching of the bearing surfaces and minor taper fretting.Root cause was of returned device was inconclusive.This report is number 2 of 2 mdr's filed for the same event (reference 1825034-2015-00719 and 1825034-2015-01783).

• Brand Name: M2A 38MM MOD HD+6MM NK NO SKRT
• Type of Device: PROTHESIS, 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: 4730667
• MDR Text Key: 15840885
• Report Number: 0001825034-2015-01783
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PK062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 11-173664
• Device Lot Number: 993620
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2005
• 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): Hospitalization; Required Intervention