MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE UNKNOWN METS DISTAL FEMUR - HINGE MECHANISM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Fracture (1260); Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2022

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.Device not returned.

Event Description

A patient specific implant prescription form was received for the patient's right knee was received.Noted on the form: "mechanical complications right knee prosthesis.Failure of hinge mechanism right knee.Stanmore distal femur revision implants and hinge mechanism.".

Event Description

A patient specific implant prescription form was received for the patient's right knee was received.Noted on the form: "mechanical complications right knee prosthesis.Failure of hinge mechanism right knee.Stanmore distal femur revision implants and hinge mechanism." update: confirmation received this is not a stanmore implant in situ.

Manufacturer Narrative

Correction: confirmation received this is not a stanmore implant in situ.Therefore this mdr is being cancelled.

• Brand Name: UNKNOWN METS DISTAL FEMUR - HINGE MECHANISM
• 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: 13524521
• MDR Text Key: 285555744
• Report Number: 3004105610-2022-00017
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121029
• 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: 05/04/2022

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: UNK_STM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 04/22/2022
• Supplement Dates FDA Received: 05/05/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 98 KG