MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONSTRAINED LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 22AM15956

Device Problem Defective Component (2292)

Patient Problem Joint Dislocation (2374)

Event Type  malfunction  

Event Description

Patient was undergoing a revision of left total hip.During surgery, the implant constrained liner 22mm i.D., 52mm o.D., provided by smith and nephew rep., was not working.The hip kept dislocating and the surgeon had to ask for another of the same implant, which the rep did not immediately have available.This delayed the surgery and resulted in unnecessary prolonged anesthesia time.The patient had no adverse event.Fda safety report id# (b)(4).

• Brand Name: CONSTRAINED LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 15362910
• MDR Text Key: 299456401
• Report Number: MW5111878
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22AM15956
• Device Lot Number: 22AM15956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Male