MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMORAL REPLACEMENT - AXLE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number PIN23003

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 05/05/2023

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.H3 other text : device not returned.

Event Description

It was reported that the patients axle has become loose and needs to be revised.

Manufacturer Narrative

Reported event: an event regarding backing out involving a patient specific, distal femoral replacement, axle, was reported.The event was 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: this 26-year-old patient underwent a distal femoral replacement prosthesis with a hinge type implant.After less than one year it was found that the axle of the implant had broken.I can confirm that the patient underwent the distal femoral replacement since i was able to review the x-ray.As of this time no revision was carried out according to the summary but an explant facility was mentioned.The root cause of this event cannot be determined with certainty.The causes of axle fracture and failure in a distal femoral replacement prosthesis in a young patient is multifactorial including surgical technique factors in the way the implant was assembled and inserted, patient factors including activity level and bmi, and implant factors.Any portion of the explanted prosthesis should be returned to stryker engineers for examination and evaluation.Device history review: review of the product history records indicate the device was 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 operative reports, progress notes, additional 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

It was reported that the patients axle has become loose and needs to be revised.Additional information: our client underwent a left knee replacement surgery in (b)(6) 2022 as an nhs patient.She had had a giant cell tumour which had fractured her femur pre-operatively and she required a left knee replacement.Her instructions are that she had to have a custom implant inserted due to her small stature.Our client was informed in (b)(6) 2023 at the hospital following an x-ray that the knee replacement had failed and that she required revision surgery.Her surgery was complicated and delayed as she was pregnant, so a hospital bed and facilities had to be found with obstetric and neonatal support for her and her unborn child.The revision surgery was performed on (b)(6) 2023.

• Brand Name: DISTAL FEMORAL REPLACEMENT - AXLE
• 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: 16944301
• MDR Text Key: 315352183
• Report Number: 3004105610-2023-00057
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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 Expiration Date: 01/31/2023
• Device Catalogue Number: PIN23003
• Device Lot Number: PIN23003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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: 26 YR