MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP 54MM WITH IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74120154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Us legal: it was reported that elevated cobalt and chromium levels were detected in the right hip.The patient¿s test results indicated elevated ion levels even after the revision surgery of the left bhr hip system (covered under (b)(4)).It was not reported if a revision surgery is planned for this patient.

• Brand Name: ACETABULAR CUP HAP 54MM WITH IMPACTOR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire ; UK
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX ; 5123913905
• MDR Report Key: 11999868
• Report Number: 3005975929-2021-00315
• Device Sequence Number: 19107244
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/30/2024

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
• Operator of Device: Health Professional
• Device Model Number: 74120154
• Device Catalogue Number: 74120154
• Device Lot Number: 090128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 11/05/2021; 11/05/2021; 04/23/2024
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 11/07/2021; 04/17/2024; 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2746-2015
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART NUMBER: 74121146 / LOT NUMBER: 088416
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female