MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM DIA COCR MOD HEAD +3MM 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); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 03/10/2008

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent total left hip arthroplasty on (b)(6) 2006.Patient's legal counsel reports patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, difficulty walking, loosening, elevated metal ions, metal poisoning, and metallosis.It was further reported that a revision procedure was performed on (b)(6) 2007 and (b)(6) 2008.Review of invoice history indicated the modular head was removed and replaced during the (b)(6) 2007 procedure.Review of invoice history further indicated the modular head was removed and replaced during the (b)(6) 2008 procedure.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 1 states, ¿material sensitivity reactions.¿ number 4 states, ¿loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." 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.¿ this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-03029 / 03030).

Manufacturer Narrative

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

Event Description

Legal counsel for patient reported patient underwent total left hip arthroplasty on (b)(6) 2006.Patient's legal counsel reports patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, difficulty walking, loosening, elevated metal ions, metal poisoning, and metallosis.It was further reported that a revision procedure was performed on (b)(6) 2007 and (b)(6) 2008.Review of invoice history indicated the modular head was removed and replaced during the (b)(6) 2007 procedure.Review of invoice history further indicated the modular head was removed and replaced during the (b)(6) 2008 procedure.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received in the operative report noted patient underwent a left hip revision procedure on (b)(6) 2008 due to instability.Operative report further noted the presence of non-purulent fluid.The modular head was removed and replaced with a biomet head and a competitor liner.

• Brand Name: 32MM DIA COCR MOD HEAD +3MM 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: 3765922
• MDR Text Key: 4379553
• Report Number: 0001825034-2014-03030
• 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: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 163670
• Device Lot Number: 845070
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2006
• 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: 41 YR