MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFLECTION PRIMARY LREF XLPE 36 0 LAT +4 54-56 F

Catalog Number 71333495

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Osteolysis (2377)

Event Date 03/23/2015

Event Type  Injury  

Event Description

A revision was performed due to aseptic loosening/osteolysis.

Manufacturer Narrative

Manufacturer Narrative

Correction: the part/batch number previous identified in the initial mdr was provided in error.The explanted part/batch number is unknown.

Manufacturer Narrative

Manufacturer Narrative

The associated complaint device was not returned.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.

• Brand Name: REFLECTION PRIMARY LREF XLPE 36 0 LAT +4 54-56 F
• Type of Device: REFLECTION PRIMARY L
• 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: lisa hassell ; 1450 brooks road; memphis, TN 38116 ; 9013991128
• MDR Report Key: 4667741
• MDR Text Key: 5622813
• Report Number: 1020279-2015-00176
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2023
• Device Catalogue Number: 71333495
• Device Lot Number: 13EM20266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2013
• 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
• Patient Age: 56 YR
• Patient Weight: 70