MAUDE Adverse Event Report: BIOMET ORTHOPEDICS REGEN/RNGLC+ LTD 52MM SZ 23; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Inflammation (1932); Irritation (1941); Pain (1994); Scarring (2061); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Ambulation Difficulties (2544)

Event Date 10/30/2013

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent right total hip arthroplasty on (b)(6) 2009 and left total hip arthroplasty on (b)(6) 2010.Patient's legal counsel reports patient allegations of pain, inflammation, lack of mobility, elevated metal ion levels, and bone/tissue damage.Subsequently, the patient¿s left hip was revised on (b)(6) 2011.All components were removed and replaced.Additionally, the patient¿s right hip was revised on (b)(6) 2012.All components were removed and replaced.No further information has been provided to date.Review of invoice history indicates the patient underwent bilateral femoral resurfacing procedures on (b)(6) 2009 and (b)(6) 2010.Patient was revised to bilateral total hip arthroplasties on (b)(6) 2011 and (b)(6) 2012.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received in the (b)(6) 2011 right hip revision operative report noted the revision was due to pain and a loose acetabular cup.Operative report further noted the presence of fluid, metallosis, and metal staining on the acetabulum.All components were removed and replaced.Additional information received in the (b)(6) 2011 left hip revision operative report noted the revision was due to pain and a loose acetabular cup.Operative report further noted the presence of fluid and sterile irritation from the loosening of the cup.All components were removed and replaced.An additional left revision procedure was performed on (b)(6) 2013 due to a pain and a loose acetabular cup.Operative report further noted the presence of fluid, black debris for metallosis, metallosis tissue, scar tissue, a protrusion with no floor, bone loss, a broken screw and an anterior fracture with disassociation of the anterior portion of the pelvis.The modular head, acetabular cup, liner and taper adapter were removed and replaced.

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: "material sensitivity reactions.¿ and "intraoperative or postoperative bone fracture and/or postoperative pain." and "loosening or migration of implants may occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity."this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.This report is number 5 of 6 mdrs filed for the same patient (reference 1825034-2013-05881/-05882/-05883/-05884 & 2014-5026/-05027).

• Brand Name: REGEN/RNGLC+ LTD 52MM SZ 23
• 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: 3840340
• MDR Text Key: 15110464
• Report Number: 0001825034-2014-05026
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: PT-116052
• Device Lot Number: 243720
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2008
• 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: 57 YR