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

Catalog Number 71335854

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Reaction (2414)

Event Date 09/10/2014

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to an adverse reaction to metal debris.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to an adverse reaction to metal debris (multilobular cyst).During the revision the modular head, sleeve and r3 liner were removed.The r3 shell and stem remain implanted.As of today, device return and additional information has been requested for this complaint but has not become available.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.The available medical documents were reviewed.This is a complaint from the r3 (b)(6)study, reporting adverse event #1 for subject 01 083 is re opened to review newly submitted information.The primary surgery was performed january 2010.2½ years later the patient was diagnosed with a "mulitlobular cysts" deemed to be armd.The new information is the report of the revision surgery, on september 10, 2014 (4 years and 9 months post implantation).The event is now stated as resolved.No cobalt or chromium laboratory values, intra operative pictures/x rays nor reports were provided for review.The device has not been returned for evaluation at this point.The study was terminated on february 27, 2015.Based on the limited clinical/medical information and no product, a complete investigation cannot be made and the reported issue cannot be supported or confirmed.No current information on the patient's status has been provided.Should any relevant 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.

Manufacturer Narrative

Previous submission missing h6 codes.

• Brand Name: R3 COCR LINER 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: 7023966
• MDR Text Key: 91771929
• Report Number: 3005975929-2017-00391
• 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: 08/15/2018

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
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 71335854
• Device Lot Number: 08GW18027
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 11/10/2017; 11/10/2017
• Supplement Dates FDA Received: 08/15/2018; 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR SHELL, # 71331854, LOT # 09GM09151; FEMORAL STEM, # 71306113, LOT # 09KM05143; MODULAR HEAD, # 74222142, LOT # 09EW23275; MODULAR SLEEVE, # 74222100, LOT # 09BW21796; ACETABULAR SHELL, # 71331854, LOT # 09GM09151; FEMORAL STEM, # 71306113, LOT # 09KM05143; MODULAR HEAD, # 74222142, LOT # 09EW23275; MODULAR SLEEVE, # 74222100, LOT # 09BW21796
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 75