MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 42OD 22ID; BIPOLAR SYSTEM

Catalog Number 71322042

Device Problems Disassembly (1168); Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a revision hip surgery was performed after the patient fell out of bed and dislocated the implants.The doctor tried reduction of the hip and it disassembled and therefore performed the revision surgery to replace the implants.

Manufacturer Narrative

The associated complaint devices were returned and evaluated.A visual inspection of the returned devices revealed the devices are intact with no obvious signs of damage.The locking ring has minor surface marring and scratches.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 research lab noted there were no visible signs of damage to the shell, liner, or locking ring.A simple functional test showed that the locking ring was able to seat in the shell and lock in place.The locking ring did not dissociate from the shell and liner with the application of manual force.The femoral head did not display signs of damage to the articulating surface or taper bore.No manufacturing deviations were noted from the visual inspection.Based on the analysis conducted, the exact cause of the reported complaint was not able to be determined.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.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.We consider this investigation closed.

• Brand Name: TANDEM BIPOLAR COCR 42OD 22ID
• Type of Device: BIPOLAR 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: 5352425
• MDR Text Key: 35315544
• Report Number: 1020279-2016-00028
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2015

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: 71322042
• Device Lot Number: 14FM12408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2015
• Initial Date FDA Received: 01/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2014
• 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; Required Intervention