MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-T UNIV 2-HOLE SHL SZ 41/52; PROSTHESIS, HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/08/2012

Event Type  Injury  

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.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 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 2 of 2 mdrs filed for the same event (reference 1825034-2014-03941 / 03942).

Event Description

Legal counsel for patient reported patient underwent a right total hip arthroplasty on (b)(6) 2001.Subsequently, patient's legal counsel reported patient was revised on (b)(6) 2012 due to patient allegations of pain and bone/tissue damage.All components were removed and replaced with cement spacer molds.Patient underwent reimplantation procedure on (b)(6) 2013.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.There are warnings in the package insert that state that these types of events can occur under possible adverse effects: 8) dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.This report is number 2 of 4 mdrs filed for the same patient (reference 1825034-2014-03941 / 03942 and 06084 / 06085).

Event Description

Legal counsel for patient reported patient underwent a right total hip arthroplasty on (b)(6) 2001.Subsequently, patient's legal counsel reported patient was revised on (b)(6) 2012 due to patient allegations of pain and bone/tissue damage.All components were removed and replaced with cement spacer molds.Patient underwent reimplantation procedure on (b)(6) 2013.Additional information received in patient medical records indicates that the initial right hip procedure occurred on (b)(6) 2003.Additional information received in patient medical records indicates that the first stage of a two stage revision of the right hip occurred on (b)(6) 2012 was due to infection; components removed and placement of an antibiotic spacer was performed.The operative report dated (b)(6) 2012 noted soft tissue reaction, lesion, and draining wound.The second stage revision of the right hip occurred on (b)(6) 2012.Medical records further indicate patient is bilateral.Additional information received in patient medical record indicates the initial left hip arthroplasty occurred on (b)(6) 2001.Additional information received in patient medical records report a left hip revision dated (b)(6) 2012 was due to a dislocation of acetabular component; head and cup replaced.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

• Brand Name: M2A-T UNIV 2-HOLE SHL SZ 41/52
• 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: 3808926
• MDR Text Key: 19323968
• Report Number: 0001825034-2014-03942
• 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: Other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2001
• Device Model Number: N/A
• Device Catalogue Number: 15-103682
• Device Lot Number: 208840
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2001
• 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: 70 YR