MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A TPR HI CARBON 41/32MM LNR; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patient mentioned in the journal article.(b)(6).

Event Description

Information was received based on review of a journal article titled, "comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study" which aimed to investigate potential advantages of magnum group compared to conventional group in terms of range of motion, dislocation while maintaining the same function improvement and pain reduction; and to investigate metal ion release in asian population.A patient was identified in the article that underwent total left hip arthroplasty on (b)(6) 2011.Subsequently, elevated metal ions, increased cup inclination angle and cup anteversion were reported.There has been no further information provided and the patient outcome is unknown.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

Information was received based on review of a journal article titled, "comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study" which aimed to investigate potential advantages of magnum group compared to conventional group in terms of range of motion, dislocation while maintaining the same function improvement and pain reduction; and to investigate metal ion release in asian population.A patient was identified in the article that underwent total left hip arthroplasty on (b)(6) 2011.Subsequently, pain, discomfort, elevated metal ions, increased cup inclination angle and cup anteversion were reported.There has been no further information provided and the patient outcome is unknown.

• Brand Name: M2A TPR HI CARBON 41/32MM LNR
• 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: 5891077
• MDR Text Key: 52606602
• Report Number: 0001825034-2016-03201
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 15-105044
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58