MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA JTS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Skin Erosion (2075)

Event Date 04/29/2022

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.

Event Description

A patient specific prescription form has been received requesting a revision device due to infection and skin loss.Additional notes on the form "perform a dair.I need to change the bushes, axle and circlip.".

Manufacturer Narrative

Reported event: an event regarding infection of jts, proximal tibia replacement was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided x-rays by clinical consultant indicated: the implant in situ was for jts proximal tibial replacement which was inserted on (b)(6) 2022.The surgeon reported that the patient requires a dair procedure due to implant infection.The x-ray images provided show that the implant is in good position and well fixed.There is no clear osteolysis or bone defects being observed.Therefore, the radiographic review cannot confirm the clinical report which may need to combine clinical symptoms and microbiological findings.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 there have been no other events for the sterile 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.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.Catalog numbers and lot codes of other devices listed in this report: smbpr02 smiles knee bumpers standard proximal tibia jts, bumper pad lot b31134 smbsh02 smiles knee bushes standard proximal tibia jts, bushing lot b31370 smcic01 smiles knee circlip mk2 proximal tibia jts, circlip lot b26182 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

A patient specific prescription form has been received requesting a revision device due to infection and skin loss.Additional notes on the form "perform a dair.I need to change the bushes, axle and circlip.".

• Brand Name: PROXIMAL TIBIA JTS
• 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: 14468703
• MDR Text Key: 293572737
• Report Number: 3004105610-2022-00083
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K092138
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 22937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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: 11 YR
• Patient Sex: Male