MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIAL REPLACEMENT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNK_STM

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646)

Event Date 01/31/2023

Event Type  Injury  

Event Description

The following was reported: a patient specific implant request form was received for the patient's left knee distal femoral replacement with proximal tibial replacement.Revision planned due to loose, infection and distal femoral replacement linked to a proximal tibial replacement with poor bone stock.Conversion of distal femoral replacement to total femoral replacement.

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.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.Catalog numbers and lot codes of other devices listed in this report: stanmore knee bushes pair m/f; cat # stbsh01-02; lot # b21843; qty: 2.Smiles knee circlip mk2; cat # smcic01; lot # b22031; qty: 2.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Manufacturer Narrative

Reported event: an event regarding loosening & infection involving a patient specific, proximal tibial replacement, proximal tibia 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: the implant in situ was for distal femoral and proximal tibial replacements which was inserted in (b)(6) 2004 and (b)(6) 2018.The surgeon reported loosening and infection of the distal femoral implant.The ct image provided showed severe radiolucent line along the femoral stem with massive bone resorption, remodelling and bone defects, indicating the loosening of the femoral stem, which may partially be caused by infection.The tibial stem had reasonably good fixation with thin radiolucent line between the cement mantle and the bone.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, additional 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.

Event Description

The following was reported: a patient specific implant request form was received for the patient's left knee distal femoral replacement with proximal tibial replacement.Revision planned due to loose, infection and distal femoral replacement linked to a proximal tibial replacement with poor bone stock.Conversion of distal femoral replacement to total femoral replacement.

• Brand Name: PROXIMAL TIBIAL REPLACEMENT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 16442912
• MDR Text Key: 310237349
• Report Number: 3004105610-2023-00019
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/04/2023

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: 07/31/2004
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 10521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2004
• 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: 52 YR
• Patient Sex: Female