MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN LEGION IMPLANT; PRSTHESSHIPHMITRUNNINBARNGFMRALMETALPLYACTAL

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

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

Event Date 11/13/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to wear and tear.Liner and head exchanged.Primary surgery performed by same surgeon about 15 years ago at the same hospital.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, per communications, neither the requested clinical information nor the device will be provided for inclusion in this investigation.Without the relevant clinical information, a thorough medical investigation cannot be rendered.Should any additional clinical information be provided, this complaint will be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The potential probable cause of this event is likely wear.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 devices or 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: UNKNOWN LEGION IMPLANT
• Type of Device: PRSTHESSHIPHMITRUNNINBARNGFMRALMETALPLYACTAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9443865
• MDR Text Key: 170032126
• Report Number: 1020279-2019-04347
• 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: 03/05/2020

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention