MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 M/+4

Catalog Number 75100857

Device Problem Disconnection (1171)

Patient Problem Injury (2348)

Event Date 07/27/2018

Event Type  Injury  

Event Description

It was reported that during trial reduction of the hip, the femoral head trial popped off and became lodged deeply in the patient's body.The surgical had difficulty retrieving the head and xray was called in to assist.After 45 mins the decision was made to make an additional incision at the waist line to remove trial head.

Manufacturer Narrative

Results: a complaint was reported due to the disconnection of a global trial femoral head during trial reduction.No part was returned for investigation.No batch number was communicated.Similar connection issues have been reported for the global trial femoral heads.Further investigations have attributed the root cause of the issue to insufficient design specifications.Improvements of the design of this instrument are ongoing.

• Brand Name: TRIAL FEMORAL HEAD 36 M/+4
• Type of Device: TRIAL FEMORAL HEAD 36 M/+4
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar, 06340 ; SZ 06340
• MDR Report Key: 7827041
• MDR Text Key: 118573225
• Report Number: 9613369-2018-00054
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K132435
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75100857
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention