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

Model Number N/A

Device Problems Material Erosion (1214); Unstable (1667); Metal Shedding Debris (1804); Compatibility Problem (2960)

Patient Problems Cyst(s) (1800); Synovitis (2094); Reaction (2414)

Event Date 04/03/2014

Event Type  Injury  

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 15 states, "elevated metal ion levels have been reported with metal-on-metal articulating surfaces." this report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2016-01516 / 01517).

Event Description

Patient's legal counsel reported a left hip revision approximately six years post-implantation due to alleged synovitis, elevated metal ion levels, and metallosis.Legal counsel reported synovitis and anterior acetabular cystic changes consistent with metal-on-metal bearing failure were noted during the revision procedure.This report is based on allegations set forth in plaintiff铠complaint and the allegations contained therein are unverified.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).This report is number 2 of 3 mdrs filed for the same patient (reference 1825034-2016-01516 / 01517 & 04171).

Event Description

Patient's legal counsel reported a left hip revision approximately six years post-implantation due to alleged pain, synovitis, elevated metal ion levels, and metallosis.Legal counsel alleged synovitis and anterior acetabular cystic changes consistent with metal-on-metal bearing failure were noted during the revision procedure.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information was received in patient's medical records, confirming patient was revised approximately six years post-implantation due to instability, unspecified mechanical complications, synovitis, and leg length discrepancy.Operative report indicated acetabular cystic changes, milky fluid, corrosion and a cyst filled with black material within the joint.Operative further indicated the acetabular component was malpositioned.The acetabular cup and femoral head were removed and replaced, and an active articulation bearing was implanted.

• 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: 5637912
• MDR Text Key: 44663921
• Report Number: 0001825034-2016-01517
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 15-105044
• Device Lot Number: 281020
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2007
• 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
• Patient Age: 49 YR