MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 ACETABULAR LINER 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL

Catalog Number 71335856

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 10/06/2014

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to an adverse reaction to metal debris.Liner, head and sleeve removed.

• Brand Name: R3 ACETABULAR LINER 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa
• 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, FL 5001 ; SZ 5001
• MDR Report Key: 5177712
• MDR Text Key: 29248049
• Report Number: 3005477969-2015-00286
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

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: 11/30/2018
• Device Catalogue Number: 71335856
• Device Lot Number: 08LW20242
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2015
• Initial Date FDA Received: 10/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2008
• 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: MODULAR SLEEVE, # 74222300, 08LW19888
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 75