MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTX CEM CUP POSITIONER; HIP INSTRUMENTATION

Catalog Number MT2200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 09/04/2014

Event Type  Injury  

Event Description

It was reported that surgery time was extended beyond 30 minutes.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A visual inspection of the returned devices revealed the devices are worn and show significant signs of use.The positioner and the replacement head were returned, the cup was not returned.The replacement head is still attached to the positioner.The positioner was manufactured in 1998 and the replacement head was manufactured in 2009.A review of complaint history revealed no prior complaint history for listed part/lot(s) failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.An evaluation performed by our quality department noted that mis-positioning of the cup onto the placement head will cause it to misalign and become stuck.Our investigation could not determine a specific cause of the 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.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: MTX CEM CUP POSITIONER
• Type of Device: HIP INSTRUMENTATION
• 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: 4077454
• MDR Text Key: 4852264
• Report Number: 1020279-2014-00551
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,for
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: MT2200
• Device Lot Number: 81108692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR