MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNI 12/14 TPR SLV + 0; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

Catalog Number 71326600

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

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 06/05/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to exchange the femoral head and do a hip washout due to infection.Patient had pain over the left hip area and ultrasound showed fluid collection under the left hip wound.

Manufacturer Narrative

Results of investigation: it was reported that a revision surgery was performed to exchange the femoral head and do a hip washout due to infection.Patient had pain over the left hip area and ultrasound showed fluid collection under the left hip wound.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.The device was sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the event as a potential adverse event.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.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: TANDEM UNI 12/14 TPR SLV + 0
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10210484
• MDR Text Key: 196911451
• Report Number: 1020279-2020-02841
• Device Sequence Number: 1
• Product Code: LZY
• Combination Product (y/n): N
• PMA/PMN Number: K896580
• 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: 09/07/2020

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: 71326600
• Device Lot Number: 19GM05411
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention