MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OSS 7CM SEG ELLIPT FEMORAL LT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/27/2015

Event Type  Injury  

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 4 states, "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, bone resorption, and/or excessive, unusual and/or awkward movement and/or activity." evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.This report is number 2 of 2 mdr's filed for the same event (reference 1825034-2015-04840 / 04841).

Event Description

It was reported that the patient had initial left total hip arthroplasty on (b)(6) 2011.Subsequently, the patient was revised on (b)(6) 2015 due to the femoral component disassociating from the stem taper.During the procedure, all components were removed and replaced.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 2 of 11 mdrs filed for the same event (reference 1825034-2015-04840-2 / 2015-04841-2 / 2016-00167 / 2016-00168 / 2016-00169 / 2016-00170 / 2016-00171 / 2016-00172 / 2016-00173 / 2016-00174 / 2016-00175).

Event Description

It was reported that the patient underwent a left replantation procedure with oss components on (b)(6) 2011.Subsequently, the patient was revised on (b)(6) 2015 due to the femoral component disassociating from the stem taper.The femoral stem remained implanted.All other components were removed and replaced during the procedure.Additional information received reported patient underwent an initial left total hip arthroplasty on (b)(6) 2010.Subsequently, patient was revised on (b)(6) 2011 due to instability.During the procedure the tibial bearing, femoral component and tibial component were removed and replaced.It was further reported patient was revised on (b)(6) 2011 due to infection.The tibial bearing and locking bar were removed and replaced during the procedure.Patient underwent another revision on (b)(6) 2011 due to infection.All components were removed and replaced with cement spacers.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.Review of the device confirmed the reported condition.However, a conclusive root cause of the event could not be determined.

• Brand Name: OSS 7CM SEG ELLIPT FEMORAL LT
• Type of Device: PROSTHESIS, KNEE
• 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: 5262151
• MDR Text Key: 32575714
• Report Number: 0001825034-2015-04841
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK002757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/26/2016

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 Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 150357
• Device Lot Number: 860840
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/02/2015
• Supplement Dates Manufacturer Received: 02/26/2016; 02/26/2016; 02/26/2016
• Supplement Dates FDA Received: 12/10/2015; 01/15/2016; 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2010
• 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: 59 YR
• Patient Weight: 118