MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN SMITH+NEPHEW DEV

Catalog Number UNKN00000000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that, after an unknown s&n hip system had been implanted, the patient has suffered multiple dislocations.The patient has had three revision surgeries.Case belongs to the second one.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the patient has suffered multiple dislocations and 3 revision surgeries within 2 years.This case covers the second revision.Responses to the medical documentation requests have not been received as of the date of this medical investigation.The reported root cause is the dysplastic anomaly reported separately (in the master case-2021-00043108); however, this cannot be confirmed nor concluded.The patient impact beyond the reported recurrent dislocation and subsequent revision surgery could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-opened for further evaluation.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.We consider this investigation closed.

• Brand Name: UNKN SMITH+NEPHEW DEV
• Type of Device: UNKN SMITH+NEPHEW DEV
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11797787
• MDR Text Key: 249725107
• Report Number: 1020279-2021-03910
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• 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: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN00000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention