MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 ACETABULAR LINER 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL

Catalog Number 71335852

Device Problem Metal Shedding Debris (1804)

Patient Problem Reaction (2414)

Event Date 11/21/2014

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that revision surgery of the right hip was performed due to an adverse reaction to metal debris.The liner, head and sleeve were removed, other devices remain implanted.

• Brand Name: R3 ACETABULAR LINER 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL
• 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, FL 5001 ; SZ 5001
• MDR Report Key: 5249523
• MDR Text Key: 32095777
• Report Number: 3005477969-2015-00305
• 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
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2015

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 Catalogue Number: 71335852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71306612, LOT # 10AM04748
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 76