MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 28MM COCR MOD HD +6MM NO SKIRT; PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371); Metal Shedding Debris (1804)

Patient Problems Hematoma (1884); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Complaint, Ill-Defined (2331); Toxicity (2333); Osteolysis (2377)

Event Date 03/30/2012

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a left total hip arthroplasty on (b)(6) 1999.Subsequently, patient was revised on (b)(6) 2008 due to an unknown reason.The modular head and liner were removed and replaced.Patient's legal counsel reported patient underwent another revision procedure on (b)(6) 2012 due to patient allegations of pain, bone/tissue damage, loss of range of motion and elevated metal ion levels.Patient's legal counsel further reported that greenish-grayish tissue was alleged noted during the revision procedure.The modular head, acetabular cup and liner were removed and replaced.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Operative report received noted patient underwent a left hip revision on (b)(6) 2012 due to pain and dislocations.Operative report noted the presence of greenish gray material and osteolysis.The modular head, acetabular cup and liner were removed and replaced.On (b)(6) 2012, patient underwent an additional revision due to a dislocation.Operative report noted the presence of a hematoma and a loose acetabular cup.The modular head, acetabular cup and liner were removed and replaced.On (b)(6) 2012, patient underwent an additional revision due to instability and a dislocation.Operative report noted the presence of a hematoma, detached abductors, bone chips, abrasions on the head, bone wear, focal bone fragments, and a compromised posterior wall.The modular head and acetabular cup 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: "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions." 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 6 of 7 mdrs filed for the same event (reference 1825034-2014-02309 /-02351 /-02352 /-06943 /-06944 /-06945 /-06946).

• Brand Name: 28MM COCR MOD HD +6MM NO SKIRT
• 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: 3994508
• MDR Text Key: 4781043
• Report Number: 0001825034-2014-06945
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK974558
• 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: 07/15/2014

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: 05/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 163638
• Device Lot Number: 384600
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2006
• 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: 65 YR