MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A TPR HI CARBON 41/32MM LNR; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 06/20/2012

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent left total hip arthroplasty on (b)(6) 2010.Patient's legal counsel further reported that all components were removed and replaced with spacers on (b)(6) 2010 and that a re-implantation procedure occurred on (b)(6) 2010.A revision procedure was reported to have taken place on (b)(6) 2012 due to patient allegations of pain, discomfort, soreness, dysfunction, and loss of range of motion.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: "postoperative bone fracture and pain." "inadequate range of motion due to improper selection or positioning of components." "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 contained therein are unverified.This report is number 8 of 8 mdrs filed for the same patient (reference 1825034-2015-02496 / 02503).

Manufacturer Narrative

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

Event Description

Legal counsel for patient reported that patient underwent left total hip arthroplasty on (b)(6) 2010.Patient's legal counsel further reported that all components were removed and replaced with spacers on (b)(6) 2010 and that a re-implantation procedure occurred on (b)(6) 2010.A revision procedure was reported to have taken place on (b)(6), 2012 due to patient allegations of pain, discomfort, soreness, dysfunction, elevated metal ions, bone/tissue damage and loss of range of motion.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.This report is number 8 of 11 mdrs filed for the same patient (reference 1825034-2015-02496 / 02503 & 04441 / 04443).

Event Description

Legal counsel for patient reported that patient underwent left total hip arthroplasty on (b)(6) 2010.Patient's legal counsel further reported that all components were removed and replaced with spacers on (b)(6) 2010 and that a re-implantation procedure occurred on (b)(6) 2010.A revision procedure was reported to have taken place on (b)(6) 2012 due to patient allegations of pain, discomfort, soreness, dysfunction, elevated metal ions, bone/tissue damage and loss of range of motion.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's left hip was revised (b)(6) 2010 due to post operative wound complications (infection) and pain.The shell, stem, and head were removed and replaced with cement spacers.Subsequently, patient was revised (b)(6) 2011 due to bilateral hip infection and pain.Operative report further noted hyperemia, purulent-looking fluid, and well-fixed stem during the revision procedure.The shell, liner, head, and stem were removed and replaced with cement spacers and an all-poly cemented cup.Patient was reimplanted on (b)(6) 2012.Operative report noted patient has had 11 procedures on his left hip regarding infections.It was also noted that prior to the (b)(6) 2012 procedure, the patient had spacers put in about 4-5 months prior ((b)(6) 2012).No information is known at this time regarding the additional procedures.

• Brand Name: M2A TPR HI CARBON 41/32MM LNR
• 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: 4828395
• MDR Text Key: 5913179
• Report Number: 0001825034-2015-02503
• 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,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 15-105044
• Device Lot Number: 478240
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2010
• 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