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

Catalog Number SMBPR01

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problem Joint Laxity (4526)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned.

Event Description

Revision of patient's knee due to instability.Notes on the form indicate "distal femur - to match design 20+ years ago.Need new tibial poly and bushings and stop plate".

Manufacturer Narrative

Corrected data d6a, g4 additional manufacturer narrative reported event: an event regarding rebushing involving a patient specific, distal femoral replacement, bumper pad was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for distal femoral replacement which was inserted on 03aug2009.The surgeon reported instability of the knee.The x-ray images provided show that the knee components were in good position and engaged well.Therefore, the radiographic review cannot confirm that the knee is unstable, which may be due to wear of the knee bearing components based on many years of the implant in situ.Device history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot.Conclusion: it was reported the patient was in need of revision due to "knee instability".On 10jan2022 the clinician's review stated the following : " [.] the radiographic review cannot confirm that the knee is unstable, which may be due to wear of the knee bearing components based on many years of the implant in situ".The implant has been in situ for approx.12 years.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology reports, progress notes, additional x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Revision of patient's knee due to instability.Notes on the form indicate "distal femur - to match design 20+ years ago.Need new tibial poly and bushings and stop plate" update 10jan2022: " [.] the radiographic review cannot confirm that the knee is unstable, which may be due to wear of the knee bearing components based on many years of the implant in situ".

• 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: 12690674
• MDR Text Key: 278180294
• Report Number: 3004105610-2021-00141
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Catalogue Number: SMBPR01
• Device Lot Number: B5035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2007
• 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: 50 YR
• Patient Sex: Female