MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 55OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 71322055

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 04/09/2021

Event Type  Injury  

Event Description

It was reported that after thr surgery performed five weeks before revision surgery, the patient experienced an infection ((b)(6) bacteraemia).The revision surgery was performed on (b)(6) 2021.The following devices were explanted from the patient: cpcs ss prim so 12/14 sz 3 ((b)(4)), tandem bipolar cocr 55od 28id ((b)(4)) and cocr 12/14 fem head 28 +0 ((b)(4)).New devices were implanted.The patient outcome is unknown.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the requested medical/surgical records and x-rays are not available; therefore, a thorough medical assessment cannot be rendered.The clinical root cause for the bacterial infection remains unknown.The patient impact beyond the reported infection and revision procedure itself cannot be determined.Should additional information/documentation become available, the clinical/medical task may be re-opened for further evaluation.No further medical assessment is warranted at this time.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TANDEM BIPOLAR COCR 55OD 28ID
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11781925
• MDR Text Key: 249227624
• Report Number: 1020279-2021-03815
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010492548
• UDI-Public: 03596010492548
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71322055
• Device Catalogue Number: 71322055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention