MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT STEM EXTRACTOR UNIV JOINT; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Model Number 71355107

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/23/2021

Event Type  Injury  

Event Description

It was reported that, during revision surgery, while trying to explant the stem, the threads of the universal joint stem extractor broke off inside the patient in the threaded proximal portion of the stem.All pieces were retrieved.The procedure was completed without delay using a smith and nephew back-up device.No other complications were reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.Per photos attached to complaint, the threads are broken off the device confirming the stated failure.The threads are shown in the photo with the device.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 repeated use can occur.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.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: REDAPT STEM EXTRACTOR UNIV JOINT
• Type of Device: PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11689758
• MDR Text Key: 246225869
• Report Number: 1020279-2021-03214
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 00885556223697
• UDI-Public: 00885556223697
• Combination Product (y/n): N
• PMA/PMN Number: K121627
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71355107
• Device Catalogue Number: 71355107
• Device Lot Number: 11LPG0004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention