MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP CEMENT FMRL HD RESUR 54M; PROSTHESIS, HIP

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Tissue Damage (2104); Toxicity (2333); Osteopenia/ Osteoporosis (2651)

Event Date 10/28/2009

Event Type  Injury  

Event Description

Patient¿s legal counsel reported that patient underwent a right hip resurfacing on (b)(6) 2005 in which m2a-recap components were implanted.Subsequently, patient underwent a revision procedure on (b)(6) 2009 due to patient allegations of pain, elevated metal ion levels, metal wear, metal poisoning, bone death, tissue death, and lesions.Lawsuit alleges brownish red motor oil colored fluid was noted during revision procedure.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 related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "material sensitivity reactions.¿ and "intraoperative or postoperative bone fracture and/or postoperative pain." and "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 1 of 2 mdrs filed for the same event (reference 1825034-2014-04549/-04550).

Manufacturer Narrative

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

Event Description

Patient's legal counsel reported that patient underwent a right hip resurfacing on (b)(6) 2005 in which m2a-recap components were implanted.Subsequently, patient underwent a revision procedure on (b)(6) 2009 due to patient allegations of pain, elevated metal ion levels, metal wear, metal poisoning, bone death, tissue death, and lesions.Lawsuit alleges brownish red motor oil colored fluid was noted during revision procedure.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) 2009 due to pain, a fluid collection, and elevated metal ion levels.Operative report noted the presence of brownish red motor oil colored fluid, brown-grey bursa consistent with metal reaction and inflammation.The modular head and acetabular cup were removed and replaced with competitor's components.

• Brand Name: RECAP CEMENT FMRL HD RESUR 54M
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3825319
• MDR Text Key: 4500664
• Report Number: 0001825034-2014-04549
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK021799
• 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: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2014
• Device Model Number: N/A
• Device Catalogue Number: US157254
• Device Lot Number: 221750
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2004
• 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: 63 YR