MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71337652

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 02/14/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due recurrent dislocations.Liner was removed.No delay reported and no backup device was required.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and it has been communicated via email that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.Therefore based on insufficient information, no further clinical assessment can be performed at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 20 DEG XLPE ACET LNR 32MM 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
• MDR Report Key: 8400242
• MDR Text Key: 138123150
• Report Number: 1020279-2019-00972
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598493
• UDI-Public: 03596010598493
• 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: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71337652
• Device Lot Number: 17EM08481
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention