MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 42MM ID US COCR LNR 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341154

Device Problems Corroded (1131); Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Test Result (2695)

Event Date 03/28/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery from the left hip was performed due to metallosis, synovitis, trunniononsis and pain.

Manufacturer Narrative

It was reported that left 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 have not become available.A review of the complaint history for the head / shell / liner / sleeve / stem 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 shell, liner and stem.Similar complaints have been identified for the head and sleeve and this will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.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.The available medical documents were reviewed.The reported synovitis, metallosis and trunnionosis may be consistent with an adverse reaction to metal debris, but this cannot be confirmed based on the limited information provided.Without supporting lab/pathology results, radiographic images, and/or the analysis of the explanted components, the root cause of the reported clinical symptoms cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Based on the provided death certificate, the patient¿s death 8 months post-revision, is not a result of, or related to the s&n devices or the revision.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 42MM ID US COCR LNR 54MM
• 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: 9080537
• MDR Text Key: 161242729
• Report Number: 3005975929-2019-00337
• 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: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2019
• Device Catalogue Number: 71341154
• Device Lot Number: 09AW20960
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Patient Sequence Number: 1
• Treatment: 71309112 SYN POR P HA HO STEM 12 09HM05390; 71335554 R3 3 HOLE ACET SHELL 54MM 09GM09964; 74122542 HEMI HEAD 42MM 08HW18406; 74222100 MOD SLEEVE -4 12/14 08HW18182; FEMORAL STEM, # 71309112, LOT # UNKNOWN; HEMI HEAD, # 74122542, LOT # UNKNOWN; MODULAR SLEEVE, PART # 74222100, LOT # UNKNOWN
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 76