MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335752

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 02/01/2017

Event Type  Injury  

Event Description

In (b)(6) 2017 patient had a new dislocation after a revision surgery in where the liner was exchanged performed in (b)(6) 2016 (b)(4), this dislocation was treated with closed reduction.

Manufacturer Narrative

The associated complaint devices were not returned.The clinical/medical team concluded, a review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.Credit cannot be issued for the devices.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 52MM
• 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: sarah freestone ; 101 hessle road; hull hu3 2bn; UK
• MDR Report Key: 7485441
• MDR Text Key: 107310965
• Report Number: 1020279-2018-00845
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598332
• UDI-Public: 03596010598332
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 71335752
• Device Lot Number: 15HM06356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Hospitalization; Required Intervention