MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN FEMORAL HEAD IMPL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Lot Number 04AT77783

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 05/05/2020

Event Type  Injury  

Event Description

It was reported that patient had a fall and the further diagnosis showed a ceramic head fracture with destruction of the shaft cone.On (b)(6) 2020 operative revision with shaft, head and inlay change was necessary.

Manufacturer Narrative

It has been determined that this submission is a duplicate of our report 1020279-2020-03453 and should therefore be disregarded.Our investigation into the incident will be documented via our supplemental mdr for that submission reference.

• Brand Name: UNKNOWN FEMORAL HEAD IMPL
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10304783
• MDR Text Key: 199849107
• Report Number: 9613369-2020-00149
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

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 Lot Number: 04AT77783
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 07/02/2020
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN ORTHOPAEDIC RECONSTRUCTION DEV, UNKN ORTHOPAE
• Patient Outcome(s): Hospitalization; Required Intervention