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

Lot Number PIN 19960

Device Problem Device-Device Incompatibility (2919)

Patient Problem Cancer (3262)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

Post-operative x-rays were provided to the stanmore implants design department.Based upon a review of these x-rays, it appears as though the tibial component which was supplied and implanted during this custom device procedure was an incorrect size.The investigation is ongoing.A supplemental report will be provided.

Event Description

During assembly of the tibial component, it appeared as though the metal hinge component sat high on the all-poly component, raising it a few millimeters.The component was implanted and the procedure was completed.Also, during the procedure and the following day, the surgeon shared his comments and preferences for the stanmore implants design office to consider in the design of future custom device cases.

• Brand Name: DISTAL FEMUR
• 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: 6420203
• MDR Text Key: 240650031
• Report Number: 3004105610-2016-00022
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140898
• 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: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Lot Number: PIN 19960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2016
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 96 KG