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

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Injury (2348); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/17/2014

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed.Physical injuries, pain, metallosis, swelling, inflammation, difficulty standing & walking, gait issues and lack of mobility reported.

Manufacturer Narrative

Following receipt of medical records it has been established that this submission represents a duplication of the incident previously reported via mdr 3005477969-2014-00310.Our updated results of investigation will be communicated via a follow up to that report.Please therefore disregard this submission.

• Brand Name: BHR ACETABULAR CUP
• 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: 6896729
• MDR Text Key: 87447248
• Report Number: 3005975929-2017-00325
• 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: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 09/19/2017
• Supplement Dates FDA Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention