MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 56/62; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122162
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Metal Related Pathology (4530)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Usa legal.It was reported that the patient underwent a revision surgery of the right hip on (b)(6) 2021 due to trunnionosis, inflammatory and adverse local soft tissue reaction associated with metal-on-metal bearing of hip replacement prothesis an right greater trochanteric displaced fracture (pathologic type-related to osteolysis-).The primary right bhr tha surgery was performed on (b)(6) 2009.The patient current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).

• Brand Name: ACETABULAR CUP HAP SIZE 56/62
• 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 CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13423122
• Report Number: 3005975929-2022-00033
• Device Sequence Number: 14778360
• Product Code: NXT
• UDI-Device Identifier: 03596010552334
• UDI-Public: 03596010552334
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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 Expiration Date: 08/11/2011
• Device Model Number: 74122162
• Device Catalogue Number: 74122162
• Device Lot Number: 9290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male