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

Catalog Number SMBPR02

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

Patient Problem Joint Laxity (4526)

Event Date 01/05/2023

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.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

Email received from surgeon: ".Needs rebushing and patella resurfacing." for the patient's custom made right proximal tibial replacement.Noted on a patient specific implant request form: "wear/ instability.".

Manufacturer Narrative

Reported event: an event regarding rebushing involving a patient specific, proximal tibial, bumper 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 patient specific proximal tibial replacement which was inserted on (b)(6) 2005.The surgeon requested a rebushing of the knee.The x-ray images provided showed that the femoral and tibial stems were in good alignment and fixation.There was no disengagement of the knee bearing components.However, the complete knee joint in front view of the x-ray was missing which may affect the review.Therefore, the radiographic review cannot confirm the clinical request but considering the implant was in situ over 17 years, normal wear and tear of the knee bearing components are expected.Thus, the clinical request for rebushing can be supported.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 referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including progress notes, operative reports 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

Email received from surgeon: ".Needs rebushing and patella resurfacing." for the patient's custom made right proximal tibial replacement.Noted on a patient specific implant request form: "wear/ instability".

• Brand Name: SMILES KNEE BUMPERS STANDARD
• 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: 16245350
• MDR Text Key: 308144910
• Report Number: 3004105610-2023-00012
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2010
• Device Catalogue Number: SMBPR02
• Device Lot Number: B3568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2005
• 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; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Male