MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 22.2MM DIA COCR MOD HD STD NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 04/13/2001

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 or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 8 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions." this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-02715 / 02716).Additional events for this patient reported on medwatch numbers 1825034-2016-02713 / 02714 and 02717 / 02719.Not returned by attorney.

Event Description

Legal counsel reports patient underwent a right hip revision procedure approximately one year post-implantation due to alleged dislocation.The femoral head and acetabular liner were removed and replaced.This report is based on allegations set forth in plaintiffcomplaint and the allegations contained therein are unverified.

• Brand Name: 22.2MM DIA COCR MOD HD STD NK
• 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: 5813954
• MDR Text Key: 50175983
• Report Number: 0001825034-2016-02715
• Device Sequence Number: 1
• Product Code: KMC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK853259
• 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: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2009
• Device Model Number: N/A
• Device Catalogue Number: 163651
• Device Lot Number: 907560
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/1999
• 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: 30 YR