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

Model Number BME18820

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 07/03/2014

Event Type  malfunction  

Event Description

It was reported by the surgeon that prior to the procedure, it was identified that the extra small components for the patient.All components were available for the stock held at the hospital, the patient's procedure was postponed until later in the day to allow time to prepare an extra small axle for the procedure, however, this was not prepared in time for the procedure, so the original axle was removed.

Manufacturer Narrative

A review of the manufacturing history confirms no non-conformances were identified.The device has not been returned for evaluation.Requests are being made for additional information and a supplemental report will be provided if this information is received.Please note that this custom device is similar to the mets smiles total knee replacement (k120992).

• Brand Name: CUSTOM SMILES TKR
• Type of Device: TOTAL KNEE REPLACEMENT
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE LTD.; elstree, hertfordshire ; UK
• Manufacturer Contact: sian rogers ; 210 centennial avenue; centennial park; elstree WD63S-J ; UK WD63SJ ; 082386500
• MDR Report Key: 4373450
• MDR Text Key: 15114908
• Report Number: 3004105610-2014-00164
• 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: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2014
• Device Model Number: BME18820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR