MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD. CUSTOM SMILES TOTAL KNEE REPLACEMENT

Model Number BME 19315

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2015

Event Type  malfunction  

Event Description

The surgeon reported to the sales representative that the tibial resection level on the operation drawing provided with the custom device was incorrectly marked as 8mm instead of 11mm.Also, the operation drawing showed the femoral condyle¿, as opposed to the ¿lateral condyle¿ which was necessary due to this particular patient¿s anatomy.The surgeon noticed these issues with the operation drawing prior to making any resections to the bone.Although there was a slight delay, the surgeon performed the correct cuts.The procedure was completed successfully with no consequence to the patient.

Manufacturer Narrative

A review of the device labelling and ifu confirmed that the information provided is correct.However, a review of the custom device operation drawing confirmed an incorrect resection level for the type of joint that was being implanted and an incorrect indication that the femoral resection marked was measured from the ¿medial femoral condyle¿, as opposed to the ¿lateral condyle¿.The investigation confirmed that the initial custom design was subsequently modified; i.E.Instead of poly case rotating hinge joint, it would be a rotating hinge metal case joint.The device was subsequently manufactured correctly with no abnormalities or deviations identified within the manufacturing history records, however, the operation drawing supplied with the custom device was not updated to reflect the resection level associated with a rotating hinge metal case joint.The investigation also identified that the femoral resection was marked incorrectly.This should have been identified during the final review of the documents prior to shipment.This was not identified at this time.The customs design department underwent awareness training regarding this issue on june 3 and 4, 2015.Please note that this custom device is similar to the mets smiles total knee replacement(k120992).

• Brand Name: CUSTOM SMILES TOTAL KNEE REPLACEMENT
• Type of Device: TOTAL KNEE REPLACEMENT
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE LTD.; e;stree WD6 3SJ; UK WD6 3SJ
• Manufacturer Contact: siam rogers ; elstree WD6 3-SJ ; UK WD6 3SJ ; 082386500
• MDR Report Key: 4834697
• MDR Text Key: 5903670
• Report Number: 3004105610-2015-00049
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/01/2015
• Device Model Number: BME 19315
• Device Lot Number: BME 19315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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 Age: 69 YR