MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 42MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 74122542

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 01/19/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery of the right hip was performed due to unknown reasons.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew, or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that a revision surgery of the right hip was performed due to pain, secondary to metal on metal synovitis, elevated test results and chronic right hip bursitis.

• Brand Name: HEMI HEAD 42MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora hosue; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8073804
• MDR Text Key: 127248691
• Report Number: 3005975929-2018-00456
• 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
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2013
• Device Catalogue Number: 74122542
• Device Lot Number: 08HW18400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74120148, LOT# 086645.; BHR UNKNOWN DEVICE/UNKNOWN LOT.; FEMORAL STEM, # 71357003, LOT # 07JM04546A.; MODULAR SLEEVE, # 74222100, LOT # 08EW16954.; BHR UNKNOWN DEVICE/UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR