MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 47OD 28ID; PROSTHESIS, HIP, HEMI-, FMRL,MTL/POLYMER,CMNTD OR UNEMNTD

Model Number 71324047

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Injury (2348)

Event Date 02/18/2020

Event Type  Injury  

Event Description

It was reported that the patient had s&n components since the unknown date and revision surgery was performed due to infection.Tandem intl bipolar 47od 28id was explanted.

Manufacturer Narrative

It was reported that a revision surgery was performed due to infection.The affected cobalt chrome femoral head and tandem bipolar shell/liner, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.The devices were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: TANDEM INTL BIPOLAR 47OD 28ID
• Type of Device: PROSTHESIS, HIP, HEMI-, FMRL,MTL/POLYMER,CMNTD OR UNEMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9779247
• MDR Text Key: 181729327
• Report Number: 1020279-2020-00760
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010494382
• UDI-Public: 03596010494382
• Combination Product (y/n): N
• PMA/PMN Number: K023743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71324047
• Device Catalogue Number: 71324047
• Device Lot Number: 15EM09316
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention