MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120160

Device Problems Device Appears to Trigger Rejection (1524); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Synovitis (2094); Tissue Damage (2104); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 05/28/2019

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to severe pain, failed left hip resurfacing, soft tissue damage, clicking of the hip, fluid in the left hip, elevated levels of cobalt and chromium, loss of mobility, and metallosis.Operative notes indicated fluid collection in his left hip, dead and damaged soft tissue and bone, fluid synovitis, synovial thickening, metal debris, and metallosis.

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.

• Brand Name: BHR ACETABULAR CUP 60MM
• 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: 9080370
• MDR Text Key: 158977076
• Report Number: 3005975929-2019-00331
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2013
• Device Catalogue Number: 74120160
• Device Lot Number: 091375
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71356109, LOT # 09LM03291; HEMI HEAD, # 74122554 LOT # UNKNOWN; MODULAR SLEEVE, # 74222300, LOT # 08HW18184; MODULAR SLEEVE, # 74222300, LOT # UNKNOWN; MODULAR SLEEVE, # 74222300, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR