MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE SMILES KNEE CIRCLIP MK2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number SMCIC01

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Ambulation Difficulties (2544)

Event Date 05/18/2021

Event Type  Injury  

Event Description

In elsevier's the knee journal issue 31 (2021) 97-109, distal femoral replacement - does length matter? mid-term results for distal femoral replacements (a study of 90 patients was reviewed.As per demographics provided, 43 patients were subject to revision arthroplasty and the remaining 47 patients reflect tumor surgery.Patient genders are listed as 47 males and 43 females, median age 71 for patient's subject to revision arthroplasty, all of whom had a stanmore distal femoral mets implanted between 2002 and 2019):, the following was reported for a patient who had a stanmore mets distal femoral replacement in situ: "one patient required revision surgery as the cerclage clip had come loose leading to expulsion of the axle.At revision surgery, there was no evidence of wear of the bushing and a new cerclage clip inserted with retention of the implant.".

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 catalog numbers and lot codes of other devices listed in this report: unknown axle, unknown lot.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.

• Brand Name: SMILES KNEE CIRCLIP MK2
• 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: 13966816
• MDR Text Key: 288299824
• Report Number: 3004105610-2022-00042
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SMCIC01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 03/31/2022
• 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): Required Intervention; Hospitalization