MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP CEMENT FMRL HD RESUR 42M; PROSTHESIS, HIP

Model Number N/A

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

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

Event Date 09/17/2014

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a hip resurfacing procedure on (b)(6) 2007.Subsequently, patient was revised on (b)(6) 2014 due to patient allegations of pain, damage to surrounding bone and tissue, loss of range of motion, metal poisoning, elevated metal ion levels and metallosis.Review of invoice history confirms the initial implant date, however the revision date could not be confirmed.This report is based on allegations set forth in plaintiff¿s notice and the allegations there in 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 related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "intraoperative or postoperative bone fracture and/or postoperative pain." and "material sensitivity reactions." and "inadequate range of motion due to improper selection or positioning of components." and "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 there in are unverified.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-00200 / 00201).

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 a hip resurfacing procedure on (b)(6) 2007.Subsequently, patient was revised on (b)(6) 2014 due to patient allegations of pain, damage to surrounding bone and tissue, loss of range of motion, metal poisoning, elevated metal ion levels and metallosis.Review of invoice history confirms the initial implant date, however the revision date could not be confirmed.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.Additional information received in operative report noted patient underwent a right hip revision on (b)(6) 2014 due to pain.Operative report noted the presence of gray-greenish fluid, gray green stained synovium, 3 x 3 cm defect in the medial wall, a fracture line from the anterior column to the posterior column and sciatic notch with pelvic discontinuity, fibrinous tissue, a fracture of the tip of the greater trochanter and metallosis.The modular head and acetabular cup were removed and replaced with a competitor total hip system.

• Brand Name: RECAP CEMENT FMRL HD RESUR 42M
• 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: 4419578
• MDR Text Key: 19308490
• Report Number: 0001825034-2015-00201
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK021799
• 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: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2014
• Device Model Number: N/A
• Device Catalogue Number: US157242
• Device Lot Number: 439380
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2004
• 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: 59 YR