MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PATELLAR COMP.; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 08/18/2020

Event Type  Injury  

Event Description

It was reported that the patient presented to the or with an unstable legion knee.When we opened the knee the post on the 15mm ps poly was broken.We replaced the poly with an 18mm ps hi flex poly.The patella was a little worn so it was replaced with a 41mm resurfacing patella.

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 it was communicated that the requested medical documentation/information was not available (¿i have no recollection of this case¿.Without the clinically relevant documentation, the root cause of the reported event could not be confirmed or concluded.The patient impact beyond the reported instability, intra-op finding of a broken post, and subsequent revision could not be determined.No further assessment can be rendered at this time.Should clinically relevant documentation/information and/or product evaluation findings become available, the clinical/medical task may be re-evaluated.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.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: PATELLAR COMP.
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10551565
• MDR Text Key: 207493314
• Report Number: 1020279-2020-04650
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention