MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71336450

Device Problem Misconnection (1399)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Event Description

It was reported that during a thr surgery, the doctor prepared acetabulum and took a trial of cup size 50.It was good and fixed well so he took the original reflection shell and it fixed well.He then put a 25mm screw for better fixation, then fixed liner for 32 mm head.Later he prepared the femur fix stem and took trial for the head and reduced the hip joint.When he dislocated the hip to put the original head reflection shell, the liner came out and the screw remained inside the bone (it was later removed).He tried to fix it again but did not succeed and then he took size 54 mm.This caused a delay of 30 minutes to an hour.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation, the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch/failure mode.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: REF THREE HOLE SHELL 50MM
• 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: 9517163
• MDR Text Key: 177211166
• Report Number: 1020279-2019-04587
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010454348
• UDI-Public: 03596010454348
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71336450
• Device Catalogue Number: 71336450
• Device Lot Number: 19HM06387
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR