MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE SMILES KNEE BUMPERS SMALL; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number SMBPR01

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding rebushing involving a jts distal femur was reported.The event was confirmed by medical review.Method & results: -product evaluation and results: not performed as no items were returned.-clinician review: the x-rays provided shows a slight tilt between the hinge component and tibial plateau.Considering the number of years in situ, this probably is a normal wear and tear of the knee bearing materials.-product history review: not performed as no lot number was provided.-complaint history review: not performed as no lot number was provided.Conclusions: an event regarding rebushing involving a jts distal femur was reported.The event was confirmed by medical review.The exact cause of the event could not be determined because further information such as x-rays taken post implantation and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The patient specific prescription form and complaint notification form indicate that the patient's right distal femur is being revised due to implant failure.It indicates that a new poly and new bearings are needed.The stem will stay in place, and a new axle and new femoral component will be needed to match the remaining stem and tibial component.The patient has pain in her knee and surgeon voiced concern that the implant may be bending.Update 09dec2020 - it was reported in the x-ray review that "the x-rays provided shows a slight tilt between the hinge component and tibial plateau but the x-ray has limited view to show the rest of the tibial component.Considering the number of years that the implant is in situ, this probably is a normal wear and tear of the knee bearing materials.".

• Brand Name: SMILES KNEE BUMPERS SMALL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 11080170
• MDR Text Key: 227719746
• Report Number: 3004105610-2020-00203
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SMBPR01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23 YR
• Patient Weight: 63