MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGEND HIP STEM 135DG COLLARLESS SIZE 9; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS,

Catalog Number H0212.1359

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 09/17/2020

Event Type  malfunction  

Event Description

It was reported that, during thr procedure, the surgeon broached upto size 9 stem and felt perfect fit of the canal, reduced with the trials.Then went for the final implantation, opened same size 9 stem as per our surgical technique.But the original implant sinked in the femoral canal, not like the trial broach.Then when checking with the ml and ap dimension of the stem comparing with the trial broach, implant is comparatively smaller than the broach in both the aspect.The surgeon opened next size 10 stem and implanted without broaching, which perfectly fit the canal.Surgery was not delayed more than 30 min.The patient is fine.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that smith & nephew is not the legal manufacturer for this device, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: LEGEND HIP STEM 135DG COLLARLESS SIZE 9
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10681627
• MDR Text Key: 211423001
• Report Number: 1020279-2020-05401
• Device Sequence Number: 1
• Product Code: MEH
• 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: 07/27/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2023
• Device Catalogue Number: H0212.1359
• Device Lot Number: ZA0024
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention