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

Model Number N/A

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/05/2015

Event Type  Injury  

Event Description

It was reported that patient underwent initial total hip arthroplasty on an unknown date.A revision procedure was performed in (b)(6) 2009 and the acetabular liner was replaced with a custom cemented acetabular liner.A subsequent revision procedure was performed on (b)(6) 2015 due to disassociation of cemented custom liner from the acetabular cup.The cup, head and custom liner were removed and replaced.The surgeon mentioned that the liner had been placed in anteversion in the previous operation, which explains the disassociation from the cement.

Manufacturer Narrative

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 sections could not be completed with the limited information provided.Product id - unknown; catalog number, lot number and expiration date - unknown; date implanted - unknown; (b)(6).The 510k number - unknown.Manufacture date ¿ unknown.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-01223 & 02069).

Manufacturer Narrative

This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-01223 ).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Although the products were returned no product evaluation will be conducted.A product evaluation is not needed for the returned products as, "the surgeon mentioned that the liner had been placed in anteversion in the previous operation, which explains the disassociation from the cement." the mode of failure was not device related but rather surgeon error in relation to the position and alignment of components.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-01223 & 02069).

• Brand Name: UNKNOWN HIP
• Type of Device: PROETHESIS, 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: 4776236
• MDR Text Key: 5800385
• Report Number: 0001825034-2015-02069
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2015

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
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2015
• Initial Date FDA Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: No
• 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