MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP CEMENT FMRL HD RESUR 42M; PROSTHESIS, HIP

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Metal Shedding Debris (1804)

Patient Problems Inflammation (1932); Pain (1994); Scarring (2061); Swelling (2091); Tissue Damage (2104); Complaint, Ill-Defined (2331); Reaction (2414); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent total left hip arthroplasty on (b)(6) 2006 and total right hip arthroplasty on (b)(6) 2006.Patient's legal counsel further reported that a right revision procedure was performed on (b)(6) 2011 due to patient allegations of implant loosening, implant migration, metallosis, pain, limp, swelling, tissue reaction, inflammation, scarring, damage to surrounding bone and tissue and lack of mobility.There has been no reported revision for the left hip.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received from the patient¿s revision operative (op) notes reports an erosive change in the anterior-superior portion of the femoral neck consistent with a change in the position of the femoral head and acetabular impingement.Op notes also report a brownish discoloration of the synovial fluid and osteophytes were observed.

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: "intraoperative or postoperative bone fracture and/or postoperative pain." and "inadequate range of motion due to improper selection or positioning of components.¿ and ¿loosening or migration of the implants may occur.¿ and ¿material sensitivity reactions.¿ and ¿elevated metal ion levels have been reported with metal on metal articulating surfaces.¿ this report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.This report is number 3 of 4 mdrs filed for the same event (reference 1825034-2014-02036, -02064, -04994, and -04995).

• Brand Name: RECAP CEMENT FMRL HD RESUR 42M
• 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: 3839472
• MDR Text Key: 4683285
• Report Number: 0001825034-2014-04994
• 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
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2014
• Device Model Number: N/A
• Device Catalogue Number: US157242
• Device Lot Number: 042520
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2004
• 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