MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD DISTAL FEMUR JTS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Lot Number PIN 20097

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Cancer (3262)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.

Event Description

The surgeon reported that the dimension of the passive tibial stem of the implant was incorrectly stated on the operation drawing and design proposal as a cylindrical passive stem 10.5mm diameter.The surgeon observed that the implant had a taper section, and the stem's proximal section was larger than 10.5 mm.As a result, a 20 to 30 minute delay in the procedure occurred while the surgeon prepared the stem's canal to accommodate the stem.The surgeon also expressed dissatisfaction with the tibial plateau preparation instrumentation, i.E., his preference includes a punch for the anti-rotation flanges, and a reamer for the cannulated portion of the tibial base plate poly that extends distally into the im canal.The procedure was complete successfully with no reported adverse effects to the patient.

• Brand Name: DISTAL FEMUR JTS
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE LTD; 210 centennial avenue; centennial park; elstree, hertfordshire WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park; elstree, hertfordshire WD6 3-SJ ; UK WD6 3SJ
• MDR Report Key: 6278617
• MDR Text Key: 265151763
• Report Number: 3004105610-2016-00041
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Lot Number: PIN 20097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 50 KG