MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 46MM ID INTL COCR LINER 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 71335858

Device Problem Metal Shedding Debris (1804)

Patient Problem Pain (1994)

Event Date 08/30/2016

Event Type  Injury  

Event Description

Metallosis revision hip surgery and removal/exchange of bhr mom head size 46mm, modular head sleeve -4mm and r3 acetabular liner cocr 46mm id 58mm od due to painful hip and suspicion of metallosis.

• Brand Name: R3 46MM ID INTL COCR LINER 58MM
• 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: 5983242
• MDR Text Key: 55812393
• Report Number: 3005975929-2016-00009
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2018
• Device Model Number: 71335858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2008
• 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: FEMORAL HEAD 46MM 74222146, LOT#08EW16983; MODULAR SLEEVE 74222100, LOT#08KW19684
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR