MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 28MM DIA COCR MOD HEAD STD NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 07/20/2011

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent total right hip arthroplasty on (b)(6) 2000.Patient's legal counsel further reported patient underwent a revision procedure on (b)(6) 2011 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, elevated metal ions, metallosis, and osteolysis.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.

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 6 states, "material sensitivity reactions".Number 11 states, "inadequate range of motion due to improper selection or positioning of components." number 19 states, "postoperative bone fracture and pain.".

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 2 mdr's filed for the same event (reference 1825034-2014-03552 and 06833).

Event Description

Legal counsel for patient reported patient underwent total right hip arthroplasty on (b)(6) 2000.Patient's legal counsel further reported patient underwent a revision procedure on (b)(6) 2011 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, elevated metal ions, metallosis, and osteolysis.Additional information provided in patient medical records indicate right hip revision performed on (b)(6) 2011 was due to instability.The patient's operative report noted crack in acetabular liner, cup retroverted, lysis, and scar tissue.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.

• Brand Name: 28MM DIA COCR MOD HEAD STD NK
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3787673
• MDR Text Key: 4363957
• Report Number: 0001825034-2014-03552
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK911684
• 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: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2009
• Device Model Number: N/A
• Device Catalogue Number: 163662
• Device Lot Number: 628250
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/1999
• 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: 54 YR