MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 48MM ID INTL COCR LINER 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71335860

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 11/07/2016

Event Type  Injury  

Event Description

Elevated test results study: (b)(4).Subject id: (b)(6).Adverse reaction to metal debris.

Manufacturer Narrative

• Brand Name: R3 48MM ID INTL COCR LINER 60MM
• 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: 6192525
• MDR Text Key: 62907942
• Report Number: 3005975929-2016-00072
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 71335860
• Device Lot Number: 08GW18036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Date Device Manufactured: 09/17/2008
• 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: BHR MODULAR HEAD#74222148, LOT09AW21278; MODULAR SLEEVE#74222200, LOT#09BW21805; R3 SHELL#71331860, LOT#08FM01732; STEM#71306614, LOT#09GM08079
• Patient Age: 54 YR
• Patient Weight: 73