MAUDE Adverse Event Report: BIOMET ORTHOPEDICS REGEN/RNGLC+ LTD 52MM SZ 23; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Toxicity (2333)

Event Date 09/24/2014

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.Review of sterilization certification confirms device was sterilized in accordance with (b)(4).There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, ¿early or late postoperative infection and allergic reaction.¿ 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 3 mdrs filed for the same event (reference 1825034-2015-05142 / 05143 / 05144).

Event Description

It was reported by the patient's legal counsel that patient underwent an initial right hip arthroplasty on an unknown date in 2007.Subsequently, patient was revised on (b)(6) 2013 due to allegations of pain and elevated cobalt ion levels.Patient was revised again on (b)(6) 2013 due to infection.During the procedure, all components were removed and spacers were implanted.On (b)(6) 2014, the spacers were removed and patient underwent re-implantation.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 corrected information and additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 5 mdrs filed for the same event (reference 1825034-2015-05142-1 / 2015-05143-1 / 2015-05144-1 / 2016-00256 / 2016-00257).

Event Description

It was reported by the patient's legal counsel that patient underwent an initial right hip arthroplasty on (b)(6) 2006.Subsequently, patient was revised on (b)(6) 2013 due to allegations of pain and elevated cobalt ion levels.Patient was revised again on (b)(6) 2013 due to infection.During the procedure, all components were removed and spacers were implanted.On (b)(6) 2014, the spacers were removed and patient underwent re-implantation.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received reported that during the revision procedure on (b)(6) 2013, loosening of the cup, discolored joint fluid, hypertrophic synovial tissue, and deficiency in the anterior wall were noted.Patient underwent an irrigation and debridement procedure between (b)(6) 2013 and (b)(6) 2013.Additional information further reported that during the revision procedure on (b)(6) 2013, purulent fluid and denuded fatty tissue suggestive of long term and infected hematoma were noted.A trochanteric osteotomy was performed to remove the well fixed stem and a piece of medial calcar fractured during the procedure.

• Brand Name: REGEN/RNGLC+ LTD 52MM SZ 23
• 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: 5323361
• MDR Text Key: 34248397
• Report Number: 0001825034-2015-05142
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070369
• 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: 01/11/2016

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: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: PT-116052
• Device Lot Number: 571530
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2013
• 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: 48 YR