MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNIV 2-HOLE SHL 56MM LNR SZ 24; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Disability (2371); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a left total hip arthroplasty on (b)(6) 2007 and a revision procedure on (b)(6) 2008 due to patient allegations of pain, inflammation, dysfunction, loss of range of motion, metal poisoning, metallosis, lack of mobility, swelling, damage to surrounding bone and tissue and elevated metal ion levels.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received noted patient underwent a right total hip arthroplasty on (b)(6) 2011.Operative report received for the (b)(6) 2008 left hip revision noted the revision was due to pain, avulsion of abductor tendon, and leg length discrepancy.Operative report further notes the failure of the previous abductor tendon repair and impingement of iliopsoas tendon.The acetabular cup and modular head were removed and replaced with a competitor¿s cup and a biomet head.No revision has been reported for the right hip.

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 related to the event.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." this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.This report is number 2 of 3 mdrs filed for the same event (reference 1825034-2014-03963 /-03964 /-05606).

Manufacturer Narrative

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

• Brand Name: UNIV 2-HOLE SHL 56MM LNR SZ 24
• 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: 3882308
• MDR Text Key: 4594186
• Report Number: 0001825034-2014-05619
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK092130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 14-103656
• Device Lot Number: 642650
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2011
• 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