MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 50MM; REFLECTION 3 ACETABULAR SYSTEM

Catalog Number 71335550

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a surgical delay of 45 minutes occurred due to the liner not properly inserting into cup.Issue was resolved.

Manufacturer Narrative

The associated complaint devices were returned and evaluated.This complaint reports a functional issue with implantation of a liner during surgery.A 45 minute delay in procedure was reported, however, the injury or impact to patient cannot be determined based on the information provided.No further risk to patient is anticipated based on the clinical details provided.A visual inspection of the returned devices revealed scratches on the outer diameter and the rim of the r3 shell, and surface markings on the outer diameter of the r3 ceramic liner.Severe damage and deformation are noted on the spline and overhang of r3 polyethylene liner ((b)(4)).The laser etch is also damaged on this liner.Minor markings are noted on the outer rim of the r3 polyethylene liner ((b)(4)).A quality evaluation confirms both plastic liners were able to be seated into the cup.A dimensional inspection was attempted; however damage/deformation at several features of the device would not allow for accurate measurement.The features that could be measured were to print specification.A dimensional inspection of the ceramic liner confirms the ring outer diameter is to print specification.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Our investigation did not determine a specific cause of the stated failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 3 HOLE ACET SHELL 50MM
• Type of Device: REFLECTION 3 ACETABULAR SYSTEM
• 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: 5729164
• MDR Text Key: 47521874
• Report Number: 1020279-2016-00475
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71335550
• Device Lot Number: 16CM10399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• 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
• Treatment: 71337650/16AM03412
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 63 YR