MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN EMPERION MODULAR HIP STEM; PRSTHSS,HIP,HEMI-,TRUNNION-BEARING,FEMORAL,METAL/POLYACETAL

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 07/20/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery of a broken emperion femoral stem component was performed.The patient described the mechanism for stem failure as happening when getting up from the toilet.No fractures of the surrounding bone were apparent on plain film.The stem was replaced with a 190mm redapt stem.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation, therefore the failure could not be confirmed.The clinical/medical team concluded, this complaint is from the united states and reports a broken emperion stem was revised.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKNOWN EMPERION MODULAR HIP STEM
• Type of Device: PRSTHSS,HIP,HEMI-,TRUNNION-BEARING,FEMORAL,METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10411794
• MDR Text Key: 203085682
• Report Number: 1020279-2020-03954
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/15/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention