MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE INT SHFT&STEM OVLCOL 15X36X44C; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number MSISS-O15X36X44C

Device Problem Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Inadequate Osseointegration (2646)

Event Date 10/18/2021

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.

Event Description

An implant prescription form reported imminent peri prosthetic fracture of the femur due to gross loosening of femoral component.The patient will be revised due to second stage infection.

Event Description

An implant prescription form reported imminent peri prosthetic fracture of the femur due to gross loosening of femoral component.The patient will be revised due to second stage infection.Update 07 february 2022: clinician review states " [.] the ct scan image provided shows that there were massive femoral and tibial bone remodelling and resorption, together with radiolucency along the femoral and tibial stems, indicating loosening of the stems.The femoral stem was not in line with the bone and the tip of the stem has caused periprosthetic fracture on the medial side [.]".

Manufacturer Narrative

Reported event: an event regarding loosening involving a mets, distal femoral replacement, femoral stem 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 mets distal femoral replacement, the date of insertion is (b)(6) 2014.The surgeon reported imminent peri prosthetic fracture of the femur due to gross loosening of the femoral component.The ct scan image provided shows that there were massive femoral and tibial bone remodelling and resorption, together with radiolucency along the femoral and tibial stems, indicating loosening of the stems.The femoral stem was not in line with the bone and the tip of the stem has caused periprosthetic fracture on the medial side.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate 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.

• Brand Name: INT SHFT&STEM OVLCOL 15X36X44C
• 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, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 12801817
• MDR Text Key: 284183973
• Report Number: 3004105610-2021-00153
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: MSISS-O15X36X44C
• Device Lot Number: B10601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2012
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 81 KG