MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP RESURFACING; BHR ACETABULAR CUP 52MM

Catalog Number	74122152
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Swelling (2091); Tissue Damage (2104); Toxicity (2333); Test Result (2695)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that right hip revision surgery was performed.Metallosis and aseptic lymphocyte-dominant vasculitis-associated lesion (aval) reported.
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: [208468 summary.Pdf].

• Brand Name: BIRMINGHAM HIP RESURFACING
• Common Device Name: BHR ACETABULAR CUP 52MM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 7836414
• Report Number: 3005975929-2018-00295
• Device Sequence Number: 2336647
• Product Code: NXT
• UDI-Device Identifier: 03596010552280
• UDI-Public: 03596010552280
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 05/31/2013
• Device Catalogue Number: 74122152
• Device Lot Number: 08EW17016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 08/20/2019
• 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 STEM, # 71306113, LOT # 10BM01814; HEMI HEAD, # 74122544, LOT # 09AW21516; MODULAR SLEEVE, # 74222100, LOT # 08CW16010; FEMORAL STEM, # 71306113, LOT # 10BM01814; HEMI HEAD, # 74122544, LOT # 09AW21516; MODULAR SLEEVE, # 74222100, LOT # 08CW16010
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR