MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71339550

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 10/03/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pain and dislocation.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: R3 0 DEG XLPE ACET LNR 32MM X 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8017287
• MDR Text Key: 125424486
• Report Number: 1020279-2018-02294
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598806
• UDI-Public: 03596010598806
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/14/2019

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: 71339550
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: 10/04/2018
• Supplement Dates FDA Received: 04/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention