MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE TIB. CAS. ASSY STD SHORT STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number MKRHM-STDST

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 01/11/2023

Event Type  Injury  

Event Description

Customer reported that: "35-year-old patient hospitalized for the replacement of a right knee prosthesis initially inserted on (b)(6) 2012 in the context of a carcinological resection of the lower extremity of the left femur for osteosarcoma.Since (b)(6) 2022 the patient has been complaining of frequent mechanical pain phenomena.The follow-up radiograph did not show any signs of loosening, but was consistent with prosthetic wear.Surgical decision of prosthetic revision.During the revision surgery on (b)(6) 2023, after arthrotomy, the surgeon noted major wear of the prosthetic wear of the prosthetic components and metallosis.Metallosis.A massive debridement of the of the entire joint and a synovectomy.The prosthesis could not be due to an error in the control of the devices.A new operation with implantation of a new prosthesis with an adapted size was performed on (b)(6) 2023.Anatomical and pathological samples were taken intraoperatively were taken intraoperatively on (b)(6) 2023, showing macrophages including metallic metal deposits.".

Manufacturer Narrative

Reported event: an event regarding wear involving a mets, distal femoral replacement, tibial hinge was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: the implant for review is for distal femoral/proximal tibial replacement which was inserted on (b)(6)2012.The surgeon reported major wear of the prosthesis and metallosis which were observed during debridement and synovectomy surgery.The clinical images were not provided for review.Considering that the femoral and tibial components were in situ was over 10 years, normal wear and tear including metallosis are expected.Therefore, this review can support the clinical report and surgical observation.Device history review: review of the product history records indicate devices were 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 pathology reports, additional pre and post-surgery x-rays 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: TIB. CAS. ASSY STD SHORT STEM
• 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: 16443829
• MDR Text Key: 310253071
• Report Number: 3004105610-2023-00021
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: MKRHM-STDST
• Device Lot Number: A10103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 86 KG