MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD CUSTOM SMILES TKR REPLACEMENT IMPLANT; LIMB SALVAGE SYSTEM

Model Number BME17532

Device Problem Defective Component (2292)

Patient Problems Failure of Implant (1924); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/15/2013

Event Type  malfunction  

Event Description

It was reported by the sales rep that the pt underwent a custom total knee replacement on (b)(6) 2013.During the procedure it was determined that the first tibial bearing opened did not fit.The poly peg was trimmed with telephone approval from the designer and a second tibial bearing was used.In addition to this, the tibial component was so tight within the poly bearing that it could not rotate.The implant was effectively a fixed hinge rather than rotating.Full implantation was performed and the surgery continued on to a normal conclusion.

Manufacturer Narrative

Component shafts were machined with an incomplete bore finish.Inspection for this tapered bore was not in the mfg process at the time.This has since been added.Actions were taken to correct any other incomplete taper bores and additional tooling was sourced to be used going forward.Requests are being made for additional info and a supplemental report will be provided if this info is received.Please note that this custom implant is similar to the mets smiles total knee replacement (k120992).

Manufacturer Narrative

The investigation concluded that the root cause of this event was due to a manufacturing issue.On initial receipt of the reported event, the event description was reviewed and with the limited information available at that time, a decision was made to report the event.However on completion of the investigation into the reported event it can now be concluded that the incident does not meet the three basic reporting criteria referenced in 21 cfr part 803 as a marketed device did not cause or contribute to a death or serious injury, or a marketed device has not malfunctioned where the malfunction of the device or a similar marketed device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Product surveillance will continue to monitor for trends.Corrected data: total knee replacement corrected to limb salvage system.

Event Description

It was reported by the sales rep that the patient underwent a custom total knee replacement on (b)(6) 2013.During the procedure it was determined that the 1st tibial bearing opened did not fit.The poly peg was trimmed with telephone approval from the designer and a 2nd tibial bearing was used.In addition to this, the tibial component was so tight within the poly bearing that it could not rotate.The implant was effectively a fixed hinge rather than rotating.Full implantation was performed and the surgery continued on to a normal conclusion.This is a supplemental report to 3004105610-2014-00129 ((b)(4)).

• Brand Name: CUSTOM SMILES TKR REPLACEMENT IMPLANT
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE LTD; 210 centennial avenue; centennial park; elstree, WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park; elstree, WD6 3-SJ ; UK WD6 3SJ ; 208238 650
• MDR Report Key: 4373395
• MDR Text Key: 5112143
• Report Number: 3004105610-2014-00129
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K140900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2013

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2013
• Device Model Number: BME17532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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): Required Intervention
• Patient Age: 76 YR