MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 40MM ID INTL COCR LINER 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71335852

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 11/12/2019

Event Type  Injury  

Event Description

It was reported a revision hip surgery due to painful hip.Liner exchange.

Manufacturer Narrative

It was reported that hip revision surgery was performed due to a painful hip.During the revision, the r3 liner, modular head, modular sleeve and threaded hole cover were removed.As of today, the implanted devices, all of which were used in treatment and additional information have been requested for this complaint but have not become available.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.A review of the complaint history for the liner, head and sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the liner and head.Similar complaints have been identified for the sleeve and this failure will continue to be monitored.Without definitive part/lot numbers a complete complaint history review cannot be performed for the threaded-hole cover involved.A review of the complaint history was performed using the part number for a threaded-hole cover in search of complaints involving pain throughout the lifetime of the product.Similar complaints have been identified for the threaded-hole cover and this failure will continue to be monitored.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.No medical records or evidence of have been received on this complaint.The reported event cannot be assessed and a thorough medical assessment cannot be performed.When notification has been made that all medical documentation has been provided, this complaint will be re-evaluated and a thorough medical assessment rendered.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 40MM ID INTL COCR LINER 52MM
• 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: 9440240
• MDR Text Key: 170020343
• Report Number: 3005975929-2019-00426
• 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
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 71335852
• Device Lot Number: 08DW16753
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODULAR HEAD 74222140/08AW15366.; MODULAR SLEEVE 74222100/ 08FW17504.; THREADED HOLE COVER 71336500/ UNKNOWN.
• Patient Outcome(s): Hospitalization; Required Intervention