MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STEM IMPACTOR ROD; PROSTHESIS, HIP, SEMI-CONSTRAINED, MET/POLY, CEMENT

Catalog Number 71364011

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 04/30/2020

Event Type  Injury  

Event Description

It was reported that while trying to assemble the synergy stem tray with the stem inserter pommel during the set up of a thr procedure, it was noted that the inserter pommel would not properly thread onto the stem.The surgeon changed the technique and used an impactor and was able to implant the stem without it.There were no delays in the procedure.The patient is fine.No other complications were reported.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The threads on the device are damaged/ stripped, rendering the device inoperable.The device was manufactured in 2006 and shows signs of extensive use.The medical investigation concluded that this complaint from the united states reports that the stem inserter would not connect properly.The surgeon changed the technique, used another impactor, and was able to implant the stem.There were no delays in the procedure.The patient is fine.No other complications were reported.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.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: STEM IMPACTOR ROD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, MET/POLY, CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10096391
• MDR Text Key: 193054200
• Report Number: 1020279-2020-01873
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010199270
• UDI-Public: 3596010199270
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• 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: 07/22/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71364011
• Device Lot Number: 06AM15452
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 07/21/2020
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention