MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 48MM; PROSTHESIS, HIP, FEMORAL, RESURFACING

Catalog Number	74123148
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Toxicity (2333)
Date of Event	09/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that left hip revision surgery was performed due to pain and other complications.Surgeon's notes reportedly noted "impending femoral neck failure, significant pain, and elevated metal levels" and "a lot of sclerosis around where the stem of the bhr component was".
Event or Problem Description
Only the femoral head was explanted while the acetabular cut was left in situ.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: FEMORAL HEAD 48MM
• Common Device Name: PROSTHESIS, HIP, FEMORAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 6705133
• Report Number: 3005975929-2017-00205
• Device Sequence Number: 16631644
• Product Code: KXA
• UDI-Device Identifier: 03596010552303
• UDI-Public: 03596010552303
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 74123148
• Device Lot Number: 10FW28564
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2017
• Supplement Date Received by Manufacturer: 06/24/2017; 06/24/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 01/09/2018; 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEMORAL HEAD, # 74123148, LOT # UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR