MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 38MM ID US COCR LINER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341150

Device Problems Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Test Result (2695); No Code Available (3191)

Event Type  Injury  

Event Description

Patient underwent revision surgery on unknown date.Implanted (b)(6) 2009 following femoral neck fracture.Prosthesis misalignment was diagnosed on the basis of poor hip abductor strength, a large prosthetic head (40 mm), and a cup inclination angle of 64(ideally 40¿50 to optimize wear rates).

Manufacturer Narrative

It was reported that hip revision surgery was performed on unknown date.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 part/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 r3 liner in search of complaints involving elevated tests results throughout the lifetime of the product.Similar complaints have been identified and this failure will continue to be monitored.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 clinical/medical documents are available for review.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.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: R3 38MM ID US COCR LINER 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
• MDR Report Key: 8324811
• MDR Text Key: 135672521
• Report Number: 3005975929-2019-00064
• 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
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71341150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2019
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, PART AND LOT # UNKNOWN.; MODULAR HEAD, # 74222140, LOT # UNKNOWN.; MODULAR SLEEVE, PART AND LOT # UNKNOWN.; FEMORAL STEM, PART AND LOT # UNKNOWN; MODULAR HEAD, # 74222140, LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR