MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120150

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994); Tissue Damage (2104); Injury (2348); Ambulation Difficulties (2544)

Event Date 04/20/2012

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed.Physical injuries, pain, metallosis, tissue damage, lack of mobility and gait issues reported.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that left hip revision surgery was performed on (b)(6) 2016 due to physical injuries, pain, abundant hip effusion with metallosis, elevated metal ions in blood, acetabular bone cyst, tissue damage, lack of mobility, gait issues and mechanical loosing of the components.During the revision surgery, both bhr components were replaced with a tha system from a competitor company.The patient tolerated the procedure well.This patient had also undergone a left hip aspiration in 2013 due to persistent severe pain.The primary left hip bhr surgery was performed on (b)(6) 2008.

• Brand Name: BHR ACETABULAR CUP 50MM
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6896834
• MDR Text Key: 87459839
• Report Number: 3005975929-2017-00326
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 74120150
• Device Lot Number: 077691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74121146, LOT # 076636.; FEMORAL HEAD, PART AND LOT # UNKNOWN.; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female