MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VNGD SSKPSC TIB BRG S 22X63/67; PROSTHESIS, KNEE

Model Number N/A

Device Problem Sticking (1597)

Patient Problem Unspecified Infection (1930)

Event Date 01/05/2016

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 or deviation.Review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, ¿early or late postoperative infection and allergic reaction.¿ this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-00247 / 00248).

Event Description

It was reported patient underwent initial left total knee arthoplasty on an unknown date.Subsequently, patient underwent a revision procedure on (b)(6) 2015 due to unknown reasons.During the procedure, the tibial locking bar and bearing were removed and replaced.Patient underwent a second revision on (b)(6) 2016 due to infection.During the procedure, the tibial stem was well fixed and could not be removed, resulting in a 1 to 2 hour delay in procedure.All other components were removed, and a tibial bearing and femoral cement mold were implanted.A future revision procedure has been indicated to remove the stem; however, a third revision has not been reported at this time.No further information has been provided.

• Brand Name: VNGD SSKPSC TIB BRG S 22X63/67
• 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: 5387790
• MDR Text Key: 36750271
• Report Number: 0001825034-2016-00247
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042757
• 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: 01/05/2016

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: 02/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 183832
• Device Lot Number: 997170
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• 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