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

Catalog Number 74122152

Device Problems Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Toxicity (2333); Test Result (2695)

Event Date 09/12/2016

Event Type  Injury  

Event Description

Patient underwent a left hip revision.This was completed due to reportedly having high metal ion levels and metal debris in her left hip joint.

Manufacturer Narrative

[(b)(4)].

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: [results of investigation c-0136496.Pdf].

• Brand Name: BHR ACETABULAR CUP 52MM
• Type of Device: 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
• MDR Report Key: 6322311
• MDR Text Key: 67127539
• Report Number: 3005975929-2017-00031
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: 74122152
• Device Lot Number: 08GW17670
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74123144, LOT # 08GW17744.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR