MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TEMPLATE ACCURIS; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYME

Lot Number UNKNOWN

Device Problems Fracture (1260); Material Rupture (1546)

Patient Problem Injury (2348)

Event Date 01/01/2006

Event Type  Injury  

Manufacturer Narrative

No remedial, corrective or preventive actions have been deemed necessary at this time.

Event Description

Literature case in a scientific publication, de raet et al., 2006, late spontaneous haemarthrosis: an unusual complication following an unicompartmental knee" it was reported that the patient presented with a spontaneous haemarthrosis of his right knee, 1 year after an unicompartmental knee replacement.This case showed an atraumatic rupture of the metal marker wire of an all-polyethylene inlay tibial implant, which caused a destruction of the polyethylene surface and a disseminated synovitis of the right knee.The patient was scheduled for a total knee replacement several months later.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this complaint from belgium is from a literature review; ¿de raet et al., 2006, late spontaneous hemarthrosis: an unusual complication following an unicompartmental knee"." it was reported that the patient presented with a spontaneous hemarthrosis of his right knee, 1 year after an unicompartmental knee replacement.¿ reportedly, this case showed an atraumatic rupture of the metal marker wire of the all-polyethylene inlay tibial implant, which caused a destruction of the polyethylene surface and a disseminated synovitis of the right knee.The patient required a revision to a total knee replacement.All documents and images provided in this article have been reviewed and consider and unless noted do not contribute to the clinical investigation.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: TEMPLATE ACCURIS
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYME
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10138091
• MDR Text Key: 194632355
• Report Number: 1020279-2020-02293
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K113038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention