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

Catalog Number 71335850

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 10/25/2016

Event Type  Injury  

Event Description

It was reported the implants could not be retrieved.Revised for metallosis query pelvic mass.Surgeon debrided soft tissue mass.Metallosis seen.Head and stem removed and taper wear visualised.Metal liner removed and replaced with poly liner.Femoral cement mantle reamed and smaller stem cemented in.Head trialed and definite head inserted.Hip stable.

• Brand Name: R3 38MM ID INTL 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6068895
• MDR Text Key: 58822626
• Report Number: 3005975929-2016-00039
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 71335850
• Device Lot Number: 07GW12875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2016
• Date Device Manufactured: 12/15/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BHR MODULAR HEAD#74222138, LOT#11302; CPCS DIST CENT SZ 12MM#71312412, LOT#08GM14417; MODULAR SLEEVE#74222300, LOT#9974; R3 ACTEABULAR SHELL#71331950, LOT#08AM17219A; R3 COCR LINER#71335850, LOT#07GW12875; SCREW#71332515, LOT#07KT13277; SCREW#71332535, LOT#08DT18903; STEM#71312362, LOT#08DM23466; THREADED HOLE COVER#71336500, LOT#08FM12723
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR