MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS,HIP,HEMI-,TRUNNION-BEARING,FEMORAL,METAL/POLYACETAL

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

Patient Problem Injury (2348)

Event Date 06/18/2020

Event Type  Injury  

Event Description

It was reported that in primary surgery, gii implants were received.Revision surgery was performed due to unknown reasons last month (b)(6) 2020).In that procedure, the tibia base was unfortunately implanted incorrectly rotated.The patient was fitted with the trial tibia with stem and trial inlay.Due to an incomplete delivery, the patient had to go to the operating room again the following day.2nd revision surgery was performed on the next day and correct devices were implanted.

Manufacturer Narrative

H3, h6: it was reported that 2 days after a revision surgery was performed, the patient underwent a second revision due to implanting the tibial baseplate rotated incorrectly.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device batch information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Some potential causes of the reported event could include but are not limited to surgical technique, device used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: UNKNOWN ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS,HIP,HEMI-,TRUNNION-BEARING,FEMORAL,METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10273477
• MDR Text Key: 198848757
• Report Number: 1020279-2020-03199
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention