MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN FEM HEAD MEMPHIS OX

Catalog Number UNKN01100507

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

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 09/10/2015

Event Type  Injury  

Event Description

*us legal mdl* it was reported that, after a first revision surgery had been performed on plaintiff's left hip on (b)(6) 2014 (covered under (b)(4)) , the plaintiff experienced unspecified symptoms that led to a second revision surgery, which was performed on (b)(6) 2015 to treat the adverse event.The liner and the femoral head were replaced.The plaintiff's outcome is unknown.

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, with the information provided, the clinical root cause of the reported chronic, recurrent dislocations and intraoperative findings of significant amount of fluid and old soft tissue necrosis from the metal-on-metal hip cannot be confirmed, and it cannot be concluded that the reported events and subsequent revision were associated with a mal-performance of the implant or implant failure.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Possible causes could include but are not limited to traumatic injury, patient anatomy or abnormal loading of limb.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that, after a first revision surgery had been performed on plaintiff's left hip on (b)(6) 2014 (covered under (b)(4)) , the plaintiff chronic recurrent dislocations that led to a second revision surgery, which was performed on (b)(6) 2015 to treat the adverse event.The liner, the cup, and the femoral head were replaced.The plaintiff's outcome is unknown.

• Brand Name: UNKN FEM HEAD MEMPHIS OX
• Type of Device: UNKN FEM HEAD MEMPHIS OX
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12145392
• MDR Text Key: 260929767
• Report Number: 1020279-2021-05880
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01100507
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71341015, ECH PRI FEM COMP SO SZ15, 09JM02821
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR