MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RX90 COCR ST 11.0MM X 125MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Granuloma (1876); Osteolysis (2377)

Event Date 10/21/2002

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 1 states, "material sensitivity reactions." number 4 states, ¿loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ this report is number 4 of 4 mdrs filed for the same event (reference 1825034-2014-04158 / 2016-01495 / 2016-01496 / 2016-01498).Not returned by attorney.

Event Description

Patient's legal counsel reported patient underwent left hip arthroplasty surgery on (b)(6) 2002.Legal counsel further reports patient underwent a revision procedure on (b)(6) 2003 due to allegations of pain, disability, disfigurement and elevated metal ion levels.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.It was reported that patient underwent an initial right hip arthroplasty on (b)(6) 2000.Patient underwent initial left hip arthroplasty on (b)(6) 2001.Information in operative notes reported that patient underwent a revision procedure on (b)(6) 2002 due to pain, recurrent dislocations, loosening, osteolysis, granulation tissue, inflammatory reaction, granuloma removal and tissue debridement.During the procedure, the modular head and femoral stem were removed and replaced.It was noted during the revision that the hip was already dislocated.

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 4 of 9 mdrs filed for the same patient (reference 1825034-2014-04158 and 2016-01495 / 01496 / 01498 / 02044 / 02045 / 02046 / 02048 / 02051).

Event Description

It was reported in operative notes received that patient underwent a left hip revision procedure due to pain, recurrent dislocations, loosening, osteolysis, granulation tissue, inflammatory reaction, granuloma removal and tissue debridement.During the procedure, the femoral head and stem were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

• Brand Name: RX90 COCR ST 11.0MM X 125MM
• 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: 5635179
• MDR Text Key: 44550739
• Report Number: 0001825034-2016-01498
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK942028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2016

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: 12/31/2010
• Device Model Number: N/A
• Device Catalogue Number: 149011
• Device Lot Number: 679830
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 05/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/10/2016; 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2000
• 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: 41 YR