MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71338663

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 02/01/2017

Event Type  Injury  

Event Description

It was reported that patient underwent revision surgery due to knee dislocation.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.[(b)(4)].

• Brand Name: R3 MULTI HOLE ACETABULAR SHELL 48MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau; SZ 05001
• MDR Report Key: 7044983
• MDR Text Key: 92494488
• Report Number: 1020279-2017-01066
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556021941
• UDI-Public: 00885556021941
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71338663
• Device Lot Number: 16HW14515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OXINIUM FEM HD 12/14 32MM +0/71343200/UNKNOWN; R3 20 DEG XLPE ACET LNR 32MMX48MM/71337648/UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention