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

Catalog Number UNK_STM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 06/08/2022

Event Type  Injury  

Event Description

It has been reported that: "as you can see on the imagery, the circlip has come out of this groove and the axle is coming out of the hinge".The patient had been complaining of pain for some time.No particular event: fall or other.".

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.

Event Description

It has been reported that: "as you can see on the imagery, the circlip has come out of this groove and the axle is coming out of the hinge".The patient had been complaining of pain for some time.No particular event: fall or other.".

Manufacturer Narrative

Reported event: an event regarding mets, distal femoral replacement, circlip involving disassociation was reported.The event was confirmed by x ray review.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 mets distal femoral replacement which was inserted on (b)(6) 2011.The surgeon reported that the circlip and axle have come out.The x-ray images provided show that the circlip has come out of the hinge and the axle has backed out medially.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: a review of the product history records could not be performed as the lot / batch information was not provided.Complaint history review: a complaint history review could not be performed as the lot / batch information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology reports, progress notes, 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.

• Brand Name: METS DISTAL FEMUR - CIRCLIP
• 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: 14825948
• MDR Text Key: 295048460
• Report Number: 3004105610-2022-00094
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/24/2022

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: 06/08/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 08/24/2022
• 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