MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN HIP; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Death (1802); Renal Failure (2041); Reaction (2414)

Event Type  Death  

Manufacturer Narrative

This user facility is outside of the united states.The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following could not be completed with the limited information provided: date of death - ni, date of event - ni, brand name ¿ ni, device code - ni, device info - ni, date implanted - month and day ni, date explanted - ni, (b)(6) pma/510(k) number ¿ ni , manufacture date ¿ ni.(b)(4).Product was examined by a third party.Results received from third party noted examination of the device found evidence of wear on the femoral head with spherical profile loss, fretting wear on the acetabular shell and ceramic particles embedded on the backside of the acetabular liner.This report is number 2 of 2 mdrs filed for the same patient (reference 3002806535-2016-00278 & 0001825034-2016-01680).

Event Description

Information was received based on review of a journal article titled, "fatal cardiomyopathy after revision total hip replacement for fracture of a ceramic liner" which aimed to examine the effects cobalt toxicity from a failed total hip replacement.A patient was identified in the article that alleged symptoms of fatigue, anorexia, left hip pain and weight loss.Approximately one year post-implantation, the patient underwent an aspiration of the hip and blackened fluid was removed.Patient was revised due to metallosis.All components were removed.Patient underwent cobalt chelation therapy and cobalt serum levels declined.However, the patient's clinical condition did not improve.Approximately three weeks post-revision procedure, the patient expired due to cardiomyopathy.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

Information was received based on review of a journal article titled, "fatal cardiomyopathy after revision total hip replacement for fracture of a ceramic liner" which aimed to examine the effects cobalt toxicity from a failed total hip replacement.A patient was identified in the article that alleged symptoms of fatigue, anorexia, left hip pain and weight loss.Approximately one year post-implantation, the patient underwent an aspiration of the hip and blackened fluid was removed.Patient was revised due to metallosis.All components were removed.Patient underwent cobalt chelation therapy and cobalt serum levels declined.However, the patient's clinical condition did not improve.After the revision procedure, the patient developed renal, liver and respiratory failure and their heart function decreased.Approximately three weeks post-revision procedure, the patient expired due to cardiomyopathy.

• Brand Name: UNKNOWN HIP
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5669734
• MDR Text Key: 45602307
• Report Number: 0001825034-2016-01680
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 05/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 46 YR