MAUDE Adverse Event Report: BIOMET ORTHOPEDICS REGEN/RNGLC+ MULTI 54MM SZ 23; PROSTHESIS, HIP

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Toxicity (2333); Disability (2371)

Event Date 03/26/2013

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a left total hip arthroplasty on (b)(6) 2007 and a right total hip arthroplasty on (b)(6) 2008.Legal counsel reports patient allegations of pain, inflammation, dysfunction, loss of range of motion, elevated cocr ion levels, metallosis and metal poisoning.Subsequently, patient¿s legal counsel reported patient underwent a right hip revision procedure on (b)(6) 2008.Review of invoice history confirmed the acetabular cup, modular head and taper adapter were removed and replaced.Patient¿s legal counsel further reported patient underwent a bilateral hip revision procedure on (b)(6) 2009.Additional information indicates patient underwent revision procedures on the right hip on (b)(6) 2010, (b)(6) 2011, and (b)(6) 2013 due to dislocation.A review of invoice history indicates patient underwent a revision procedure on (b)(6) 2011 on an unknown side.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.Operative reports were received for left hip revisions performed on (b)(6) 2011 and (b)(6) 2013.Information received in the revision operative notes indicates that the left hip revision performed on (b)(6) 2011 was due to pain and noted the presence of metallosis, joint effusion, staining of the capsular layer and a loose acetabular cup.The modular head and acetabular cup were removed and replaced.Operative notes received for the (b)(6) 2013 left hip revision noted the revision was due to instability and noted the presence of metallosis, a thickened crural fascial plane, straw-colored fluid, a loose acetabular cup, 2 broken screws, bone loss, and a scar ball.The acetabular cup and liner were removed and replaced with competitor¿s components.The modular head were removed and replaced.Operative reports were received for right hip revisions performed on (b)(6) 2008, (b)(6) 2009, (b)(6) 2010 and (b)(6) 2011.Operative report for the right hip revision performed on (b)(6) 2008 noted the revision was due to dislocations and noted the presence of a bloody effusion/hemarthrosis, disruption of the abductor mechanism and lack of bony ingrowth of the acetabular cup.The modular head, acetabular cup and liner were removed and replaced.Operative notes reported the right hip revision performed on (b)(6) 2009 was due to instability and noted the presence of fluid.The modular head, liner and locking ring were removed and replaced.Operative notes reported the right hip revision performed on (b)(6) 2010 was due to dislocation and noted the presence of chronic appearing seroma, fluid, a hemarthrosis/hematoma, scarring, the abductor mechanism pulled off, freedom liner was displaced and a fractured locking ring.The modular head, liner and locking ring were removed and replaced.Operative notes reported the right hip revision performed on (b)(6) 2011 was due to dislocation and noted the presence of bursitis, bloody serous fluid, inflammatory synovitis, dissociation of the modular head and liner and a fractured locking ring.The modular head, liner and locking ring were removed and replaced.M2a legal: bilateral revisions due to metal poisoning and metallosis.

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: "material sensitivity reactions.¿ and "loosening or migration of implants may occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity." and "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions." this report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.This report is number 21 of 21 mdr's filed for the same patient (reference 1825034-2014-00206 thru -00217 and -01716/-01722/ -01724 thru -01729 ).

• Brand Name: REGEN/RNGLC+ MULTI 54MM 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: 3683640
• MDR Text Key: 4292580
• Report Number: 0001825034-2014-01729
• 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: 02/17/2014

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: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: PT-106054
• Device Lot Number: 660590
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2014
• Initial Date FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2011
• 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; Required Intervention
• Patient Age: 55 YR