MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ENDO II MOD ENDO HEAD SZ 46; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Material Deformation (2976); Mechanical Jam (2983)

Patient Problems Tissue Damage (2104); Toxicity (2333); Reaction (2414); Fluid Discharge (2686); Test Result (2695)

Event Date 04/16/2014

Event Type  Injury  

Event Description

It was reported that patient underwent an initial hip arthroplasty on (b)(6) 2005.Subsequently, patient underwent a revision procedure on (b)(6) 2014, due to metallosis, fluid, and damage to muscle.Surgeon could not remove the head from the stem as they were cold welded.As a result, a delay over thirty (30) minutes was experienced.

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, number 1 states, ¿material sensitivity reactions.¿ number 10 states, ¿fretting and crevice corrosion can occur at interfaces between components." this report is number 1 of 3 mdrs filed for the same event (reference 1825034-2014-04052 / 04054).

• Brand Name: ENDO II MOD ENDO HEAD SZ 46
• 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: 3811795
• MDR Text Key: 4474464
• Report Number: 0001825034-2014-04052
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK984028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 12-139016
• Device Lot Number: 873430
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2003
• 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