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

Device Problem Unstable (1667)

Patient Problems Inflammation (1932); Pain (1994); Toxicity (2333)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

Date of initial surgery was reported to be (b)(6) 2017 but was deemed invalid considering that implantation surgery date cannot be after the revision surgery date.

Event Description

It was reported that patient underwent left hip revision surgery due to pain, bone deterioration, loss of hip function, instability, inflammation, and metallosis.

Manufacturer Narrative

It has been determined that this report is a duplicate of prior submission mdr 3005975929-2017-00416.Please therefore disregard this report.Our results of investigation for this incident will be communicated via a follow up report using mdr ref.3005975929-2017-00416.

• 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 05001 ; SZ 05001
• MDR Report Key: 7094873
• MDR Text Key: 94065781
• Report Number: 3005975929-2017-00441
• 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: 03/29/2018

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: 11/28/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 03/29/2018
• 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