MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP CEMENT FMRL HD RESUR 52M; PROSTHESIS, HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Damage to Ligament(s) (1952); Pain (1994); Tissue Damage (2104); Test Result (2695)

Event Date 08/12/2014

Event Type  Injury  

Event Description

Legal counsel for the patient reported that patient underwent left hip arthroplasty on (b)(6) 2010.Patient¿s legal counsel further reported that a revision procedure was performed on (b)(6) 2013 due to patient allegations of pain, elevated metal ions and damage to surrounding bone and tissue.A review of invoice history confirms that a hip resurfacing procedure was performed on (b)(6) 2010.Invoice history also confirms the femoral resurfacing head was removed and replaced during the revision procedure on (b)(6) 2013.Additional information received in patient medical records indicate patient is bi-lateral with a right hip arthroplasty performed on (b)(6) 2010 with no reported revision.The patient¿s operative report for the left hip revision on (b)(6) 2013 noted an area consistent with pseudotumor-type appearance.Additional information received in patient medical records noted that on (b)(6) 2013 patient¿s joint fluid was tested.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.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 14 states, ¿intraoperative or postoperative bone fracture and/or postoperative pain.¿ this report is number 3 of 3 mdrs filed for the same patient (reference 1825034-2014-01731, 05374 / 05375).

Manufacturer Narrative

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

Event Description

Legal counsel for the patient reported that patient underwent left hip arthroplasty on (b)(6) 2010.Patient's legal counsel further reported that a revision procedure was performed on (b)(6) 2013 due to patient allegations of pain, elevated metal ions and damage to surrounding bone and tissue.A review of invoice history confirms that a hip resurfacing procedure was performed on (b)(6) 2010.Invoice history also confirms the femoral resurfacing head was removed and replaced during the revision procedure on (b)(6) 2013.Additional information received in patient medical records indicate patient is bi-lateral with a right hip arthroplasty performed on (b)(6) 2010 with no reported revision.The patient's operative report for the left hip revision on (b)(6) 2013 noted an area consistent with pseudotumor-type appearance.Additional information received in patient medical records noted that on (b)(6) 2013 patient's joint fluid was tested.Additional information received noted patient underwent a right hip revision procedure on (b)(6) 2014 allegedly due to pain and adverse reaction to metal debris causing aseptic lymphocyte dominated vasculitis-associated lesions (alval) reaction.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

• Brand Name: RECAP CEMENT FMRL HD RESUR 52M
• 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: 3857086
• MDR Text Key: 21731651
• Report Number: 0001825034-2014-05375
• 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: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: US157252
• Device Lot Number: 778860
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2009
• 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
• Patient Age: 45 YR