MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD EMP11 SLV SM CONE 2 SPOUT SLOT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS

Catalog Number 71291652

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

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

Event Date 04/26/2018

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed.

Event Description

It was reported that left hip revision surgery was performed due to broken aspect of the stem.

• Brand Name: EMP11 SLV SM CONE 2 SPOUT SLOT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9080472
• MDR Text Key: 161705105
• Report Number: 3005975929-2019-00335
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K042127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 71291652
• Device Lot Number: 06HAB0039A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 09/06/2019; 01/05/2021
• Supplement Dates FDA Received: 10/22/2019; 01/06/2021
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention