MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP-DUMMY IMPLANT; PROSTHESIS, HIP, HMI-, TRNNION-BEARING, FEMRAL, MTAL/POLYACETAL

Device Problem Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 11/05/2019

Event Type  Injury  

Event Description

After a revision surgery x-rays show that the head was 32 mm instead of 28 mm as initially planned thus surgical intervention was required to explant the head.There was a 30 mins-1 hours delay.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has some damage from implantation / extraction.The device is a 32mm head and the device matches the packaging that was returned with the device.The device was manufactured in 2019.The clinical / medical investigation concluded that this complaint reports that the wrong size head was implanted in error.A 32mm head was implanted instead of the required 28mm.Doctor realized this was not right device after the device was implanted.All documents and images provided have been reviewed and do not contribute to the clinical investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.The impact to the patient beyond the immediate revision cannot be determined.The root cause of the wrong size head being implanted cannot be definitively concluded.The size difference would have been noticeable.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable causes of the reported event is likely a user error.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: HIP-DUMMY IMPLANT
• Type of Device: PROSTHESIS, HIP, HMI-, TRNNION-BEARING, FEMRAL, MTAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9401313
• MDR Text Key: 168797866
• Report Number: 1020279-2019-04259
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 02/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention