MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number R3 20 DEG XLPE ACET LNR 32MM X 48MM

Device Problem Compatibility Problem (2960)

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

Event Date 05/25/2020

Event Type  Injury  

Event Description

It was reported that after thr procedure, on (b)(6), it was found that the inner liner was suspected to fall off.On (b)(6), during the revision surgery, it was confirmed that the r3 20 deg xlpe acet lnr 32mm x 48mm fell off and was replaced with a new one.The current health state of the patient is good.

Manufacturer Narrative

It was reported that a revision surgery was performed due to device suspected to be falling off.The associated r3 20 deg xlpe acetabular liner, used in treatment, was returned and evaluated.A visual inspection of the device shows the device is severely damaged probably during explantation.Dimensional analysis could not be performed with accuracy due to the damage.A review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.This reported migration has been identified in the instructions for use and risk management files as potential adverse events.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A clinical analysis noted that the implantation surgical plan was provided along with an intraoperative picture, pictures of the liner and x-rays.The provided information did not reveal the root cause of the liner migration.It was reported that the current health of the patient is good.Some potential causes of the reported event could include but are not limited to traumatic injury, patient anatomy or size of device.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 48MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10176089
• MDR Text Key: 195799969
• Report Number: 1020279-2020-02615
• Device Sequence Number: 1
• Product Code: MBL
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: R3 20 DEG XLPE ACET LNR 32MM X 48MM
• Device Catalogue Number: 71337648
• Device Lot Number: 19EM19866
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 55