MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74120162
Medical Device Problem Codes	Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Test Result (2695); Unspecified Immune System Problem (4435); Metal Related Pathology (4530)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a right hip revision due to persistent pain, clicking sound and elevated test results.
Additional Manufacturer Narrative
Smith + nephew is submitting this report pursuant to the provisions of 21cfr, 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.- attachment: [287917 summary.Pdf].
Additional Manufacturer Narrative
D4 part number and udi corrected.Smith + nephew is submitting this report pursuant to the provisions of 21cfr, 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 or Problem Description
It was reported that, after bhr surgery had been performed on (b)(6) 2012, the patient experienced release of metals from the implants.And was diagnosed with metal toxicity.Several intervention dates were noted.The bhr implants were explanted on (b)(6) 2018 and replaced with standard prosthesis.The metallosis was determined as resolved.

• Brand Name: BHR ACETABULAR CUP 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: sarah freestone
• MDR Report Key: 9587077
• Report Number: 3005975929-2020-00015
• Device Sequence Number: 11557082
• Product Code: NXT
• UDI-Device Identifier: 03596010502629
• UDI-Public: 03596010502629
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/15/2025

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: Lay User/Patient
• Device Expiration Date: 07/31/2015
• Device Model Number: 74120162
• Device Catalogue Number: 74120152
• Device Lot Number: UNREADABLE
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 05/01/2020; 05/01/2020; 09/10/2025; 09/22/2025
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 05/05/2020; 05/06/2020; 09/10/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2010
• 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
• 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: 74121146 / LOT NUMBER 10DW26735.; FEMORAL HEAD 74121146/ 10DW26735.; FEMORAL HEAD 74121146/ 10DW26735
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male