MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71336444

Device Problem Connection Problem (2900)

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

Event Date 10/29/2018

Event Type  malfunction  

Event Description

It was reported that a patient underwent a total hip replacement.During surgery a delay greater than 30 minutes was reported due to the cup didn't fit with the liner, a bigger cup and liner size had to be implanted and fixed with bone cement.Outcome of the patient was good.

Manufacturer Narrative

The associated reflection liner and reflection 3 hole shell were returned and evaluated.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A quality hold was requested.With the information currently available, we are considering this to be an isolated event.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: REF THREE HOLE SHELL 44MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8141939
• MDR Text Key: 129608842
• Report Number: 1020279-2018-02713
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010460523
• UDI-Public: 03596010460523
• Combination Product (y/n): N
• PMA/PMN Number: K960094
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71336444
• Device Lot Number: 15MM09496
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1