MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP-DUMMY INSTRUMENT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 01/03/2018

Event Type  Injury  

Event Description

It was reported that an arthroscopic procedure was done.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No potential probable causes of this event could be concluded with the limited information provided.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: HIP-DUMMY INSTRUMENT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9390238
• MDR Text Key: 168434443
• Report Number: 1020279-2019-04183
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/28/2019
• Supplement Dates Manufacturer Received: 10/31/2019
• Supplement Dates FDA Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1