MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-T UNIV 2-HOLE SHL SZ 41/54; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Tissue Damage (2104); Toxicity (2333); Osteopenia/ Osteoporosis (2651)

Event Date 10/22/2013

Event Type  Injury  

Event Description

It was reported patient underwent a left total hip arthroplasty on (b)(6) 2002.Subsequently, a revision procedure was performed on (b)(6) 2013 allegedly at patient's request.It was further reported patient allegedly had no adverse effects from the m2a hip, but wished to proceed with revision.It was reported that all components were allegedly well-fixed and functioning properly during the revision procedure.Additional information was received from patient¿s legal counsel and reported patient allegations of pain, bone/tissue damage, dislocation, and elevated metal ion levels.Patient's legal counsel further reported lab results from an unknown date allegedly revealing cobalt serum level of 1.3 ng/ml and chromium serum level of 1.7 ng/ml.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 8 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions." number 14 states, "postoperative bone fracture and pain." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 3 of 4 mdrs filed for the same event (reference 1825034-2013-05432 & 2014-00471 / 00473).

Manufacturer Narrative

This follow-up report is being filed to relay corrected initial procedure date and additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported that patient underwent total hip arthroplasty on (b)(6) 2002.Subsequently, a revision procedure was performed on (b)(6) 2013 allegedly at patient's request.It was further reported that patient allegedly had no adverse effects from the m2a hip, but wished to proceed with revision.It was reported that all components were allegedly well-fixed and functioning properly during the revision procedure.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information was received from patient's legal counsel and reported patient allegations of pain, bone/tissue damage, dislocation, and elevated metal ion levels.Additional information received in operative report noted patient underwent a left total hip arthroplasty on (b)(6) 2002.Operative report further reported patient was revised on (b)(6) 2013 due to pain.During the revision procedure, benign fluid was noted.The modular head, acetabular cup and metal liner were removed and replaced.

• Brand Name: M2A-T UNIV 2-HOLE SHL SZ 41/54
• 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: 3581214
• MDR Text Key: 16803695
• Report Number: 0001825034-2014-00472
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 15-103684
• Device Lot Number: 173690
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2002
• 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: 38 YR