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

Catalog Number UNKN01000000

Device Problem Noise, Audible (3273)

Patient Problem Failure of Implant (1924)

Event Date 08/05/2021

Event Type  Injury  

Event Description

It was reported that, after a thr (unknown date and facility), a revision surgery on (b)(6) 2021, was performed, due to squeaking, to remove a cup and liner, and replace the femoral head.No further information including pathology results are or will be available for this case.No x-rays available.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, although the patient had the hip for considerable time, a revision was performed due to ¿squeaking¿ after having the contralateral ¿hip done¿.It was communicated that the implants will not return and no further information is or will be available.S+n has not received the device and/or adequate documentation to fully evaluate the root cause of the reported event.The patient impact beyond the reported squeaking and subsequent revision could not be determined.Should additional information/ documentation become available, the clinical/medical task may be re-opened for further evaluation.No further medical assessment is warranted 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.Some potential probable causes could be alignment or fit/size of the device used.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 ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12342773
• MDR Text Key: 267323076
• Report Number: 1020279-2021-06468
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention