MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28X50-52 20 DEG SZ E; REFLECTION ACETABULAR COMPONENT

Catalog Number 71742850

Device Problem Connection Problem (2900)

Patient Problem No Code Available (3191)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported the procedure was extended 3 hours due to improper implant connection.

Manufacturer Narrative

The associated liner was returned and evaluated.The visual inspection of the returned device shows damage not unexpected for trying several attempts to insert.A dimensional inspection was attempted; however damage/deformation at several features of the device would not allow for accurate measurement.At this time, we have no reason to suspect that the product failed to meet any product specifications.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.

Event Description

It was reported the patient had excessive bleeding.

• Brand Name: REF LNR 28X50-52 20 DEG SZ E
• Type of Device: REFLECTION ACETABULAR COMPONENT
• 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5463118
• MDR Text Key: 39116981
• Report Number: 1020279-2016-00184
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K932755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

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: 71742850
• Device Lot Number: 14FM05589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2014
• 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; Other
• Patient Age: 64 YR