MAUDE Adverse Event Report: BIOMET ORTHOPEDICS CUSTOM OSS 19X90 STEM W/PLATE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Information (3190)

Event Date 09/06/2013

Event Type  Injury  

Event Description

It was reported patient underwent a total knee arthroplasty on (b)(6) 2013 with a custom orthopedic salvage system.During the procedure, it was noted the alignment tabs on the taper portion of the expandable component did not match the mating pockets on the custom stem.The alignment tabs were removed from the expandable component in order to complete the procedure.The expandable component and custom stem were implanted.

Manufacturer Narrative

Although the device is not being returned for evaluation, the case file for the custom implants are being evaluated to determine the root cause.Upon completion of the case file evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

Evaluation of device design and device history records found implant to meet design specifications.The root cause was determined to be the inconsistency of alignment tab orientation between the oss expandable products and the rest of the oss system.This device is a custom stem and should have been designed to be compatible with the oss expandable products but was instead designed to be compatible with the other oss system products.To prevent further similar issues with alignment the oss expandable product design was changed to have the same orientation as all other oss products.

• Brand Name: CUSTOM OSS 19X90 STEM W/PLATE
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3577731
• MDR Text Key: 19299156
• Report Number: 0001825034-2014-00413
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PCUSTOM
• 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
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CP115263
• Device Lot Number: 247090
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2013
• 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): Required Intervention