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

Catalog Number UNK_STM

Device Problem Loss of Osseointegration (2408)

Patient Problems Osteolysis (2377); Inadequate Osseointegration (2646); Unequal Limb Length (4534)

Event Date 05/24/2022

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 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

A patient specific implant prescription form and email were received for the patient's right distal femoral component.Noted on the prescription form: "previous osteosarcoma, now requires revision for osteolysis.Will need to resect a further 2-3 cm from distal femur to optimize fixation.Preferably the intramedullary stem will be cemented into existing cement mantle (i.E.New stem will need to be 110-120mm in length).Jts to facilitate future lengthening's.Revise tibia to all poly tibia." noted in the email: "it looks to have some loosening in this area which has been ongoing for quite some time and he has quite a significant leg length discrepancy.I think he has got quite an area of aseptic loosening and in view of this, he will need quite a high resection point.I feel that he will require a custom made prosthesis which we might even put a non-invasive grower into it to get his length back out, as i will not be able to readjust it by surgery.".

Manufacturer Narrative

Reported event: an event regarding loosening involving a distal femoral replacement, femoral component was reported.The event was confirmed by x ray review.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 distal femoral replacement which was inserted on 07jun1994.The surgeon reported aseptic loosening of femoral stem and leg length discrepancy.The ct image provided shows gross radiolucency along the femoral stem with osteolysis, bone resorption and remodelling, especially near the bone resection.The affected femur is much shorter (around 75mm) than the opposite femur.Therefore, the radiographic review can confirm the clinical report and reason for revision.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, 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.

Event Description

A patient specific implant prescription form and email were received for the patient's right distal femoral component.Noted on the prescription form: "previous osteosarcoma, now requires revision for osteolysis.Will need to resect a further 2-3 cm from distal femur to optimize fixation.Preferably the intramedullary stem will be cemented into existing cement mantle (i.E.New stem will need to be 110-120mm in length).Jts to facilitate future lengthening's.Revise tibia to all poly tibia." noted in the email: ".It looks to have some loosening in this area which has been ongoing for quite some time and he has quite a significant leg length discrepancy.I think he has got quite an area of aseptic loosening and in view of this, he will need quite a high resection point.I feel that he will require a custom made prosthesis which we might even put a non-invasive grower into it to get his length back out, as i will not be able to readjust it by surgery.".

• Brand Name: PATIENT SPECIFIC DISTAL FEMORAL REPLACEMENT
• 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: 14741887
• MDR Text Key: 294412658
• Report Number: 3004105610-2022-00088
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 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 Expiration Date: 12/31/1994
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 3109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/1994
• 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: 44 YR
• Patient Sex: Male