MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122150

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/10/2020

Event Type  Injury  

Event Description

It was reported that a conversion bhr to tha was performed due to elevated test results (co 8 cr 9.2), cup looks to slipped and now retroverted.

Manufacturer Narrative

It was reported that hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but has not become available.Without definitive lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part number for a cup and head in search of complaints involving elevated tests results throughout the lifetime of the product.As no device batch numbers were provided for investigation, a manufacturing record review, ifu review and risk management review could not be performed.If more information is received, this investigation will be reopened.No medical records have been received on this complaint.It was reported that a revision was performed due to elevated test results.However the device will not be returned for analysis.Without supporting medical records/documentation, the reported event cannot be assessed and a thorough medical assessment cannot be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: ACETABULAR CUP HAP SIZE 44/50
• 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: 9592691
• MDR Text Key: 175099315
• Report Number: 3005975929-2020-00018
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552273
• UDI-Public: 03596010552273
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 74122150
• Device Catalogue Number: 74122150
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD 74123144/ UNKNOWN; FEMORAL HEAD 74123144/ UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention