MAUDE Adverse Event Report: BIOMET ORTHOPEDICS FREEDOM CONSTRAINED HEAD-6MM; PROTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Pain (1994); Tissue Damage (2104); Discomfort (2330); Toxicity (2333); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 11/29/2010

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent right total hip arthroplasty on (b)(6) 2010.Patient's legal counsel reports patient allegations of pain, inflammation, bone/tissue damage, dysfunction, discomfort, lack of mobility, and metallosis.Subsequently, the patient was revised on (b)(6) 2010.The acetabular component, modular head and taper adapter were removed and replaced.Additional information received in the patient¿s (b)(6) 2010 revision operative report noted a dislocation with the presence of a hematoma.The acetabular cup, modular head and taper adapter were removed and replaced.Subsequently, the patient was revised again on (b)(6) 2010 due to a dislocation.The medical report further noted the presence of a hematoma.The modular head was removed and replaced.

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: ¿material sensitivity reactions.¿ and ¿dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions.¿ this report is number 4 of 4 mdr's filed for the same event (reference 1825034-2013-05009/05011 & 2014-00059).

• Brand Name: FREEDOM CONSTRAINED HEAD-6MM
• Type of Device: PROTHESIS, 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: 3577820
• MDR Text Key: 4137210
• Report Number: 0001825034-2014-00059
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030047
• 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: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 11-107016
• Device Lot Number: 700410
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2010
• 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: 62 YR