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

Catalog Number 11/30/2018

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed before (b)(6) 2015 due to pain and a possible adverse reaction to metal debris.

Manufacturer Narrative

Part numbers corrected.

• Brand Name: R3 ACETABULAR LINER 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS; 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: 5090484
• MDR Text Key: 26265224
• Report Number: 3005477969-2015-00261
• 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
• Type of Report: Followup,Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 11/30/2018
• Device Lot Number: 08LW20228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2015
• 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: ACETABULAR SHELL, # 71331952, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 82