MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN MEMPHIS RECON KNEE INSTR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 114943

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2020

Event Type  Injury  

Event Description

It was reported that after the sterilization, before surgery, rust was found onto the device.The device was needed to be re-sterilized.It caused 45 minutes delay of surgery with patient under anesthesia.There was no backup so the device was sterilized and used in patient, the surgery could be finished.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirm the stated failure.There is rust on the laser marking of the device.The device exhibits signs of significant wear/ usage.A material check was performed and it is suspected that the laser marking is the root cause of the discoloration on the genesis calipers.It is suspected that the discoloration may be rust.A medical investigation was conducted and confirms based on the information provided, the definitive root cause of the rust could not be determined, as the provided ¿photo did not confirm the stated failure¿ per the visual product evaluation.The patient impact beyond the reported 45-minutes extension under anesthesia could not be determined; although, reportedly the procedure was completed ¿without and problems¿ and the events resulted in ¿no serious injury¿.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.This issue is being addressed through our internal nonconformance process.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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, corrective and preventive action is indicated to mitigate future recurrence of similar events.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN MEMPHIS RECON KNEE INSTR
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10203839
• MDR Text Key: 196743703
• Report Number: 1020279-2020-02797
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 114943
• Device Lot Number: 18ESA0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention