MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 LINER CERAMIC POLY; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 06/12/2017

Event Type  Injury  

Event Description

It was reported that, after a thr construct had been implanted, the patient experienced pain.A revision surgery to explant the acetabular component was performed.It is unknown whether the femoral head was explanted or not.The anthology stem remained in situ.The current status of patient is unknown.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So, the reported event could not be confirmed.A medical investigation was conducted.This is an anthology study.It was reported that, after a thr construct had been implanted, the patient experienced pain.A revision surgery to explant the acetabular component was performed.It is unknown whether the femoral head was explanted or not.The anthology stem remained in situ.The current status of patient is unknown.Smith and nephew has not received the device/ adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKN R3 LINER CERAMIC POLY
• 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: 11263563
• MDR Text Key: 229763975
• Report Number: 1020279-2021-00826
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR