MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EXT SLV REMVL TOOL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	116608
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, when trying to remove sleeve from stem, the extractor got stuck in the sleeve and the sleeve was stuck in the stem.Therefore, the stem needed to be removed with the other two devices stuck.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual examination of the returned sleeve removal tool indicated that the threaded end has fractured off.A clinical analysis indicated that based on the information provided, the root cause of the acetabular protrusion and subsequent conversion to left tha is likely disease progression.The inability to remove the sleeve from the well-fixed anthology stem via alternative means as well as the re-use removal tool which fractured were the contributing factors to the stem removal.The patient impact beyond the reported clinical symptoms, surgical extension, and l hip revision/conversion to tha with an extensive osteotomy and intraoperative complications cannot be determined.No further medical assessment is warranted at this time.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: EXT SLV REMVL TOOL
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7697382
• Report Number: 1020279-2018-01313
• Device Sequence Number: 1451919
• Product Code: JDI
• UDI-Device Identifier: 03596010416322
• UDI-Public: 03596010416322
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 116608
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/30/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR