MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNIPOLAR 51MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

Model Number 126651

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

Patient Problem Unspecified Infection (1930)

Event Date 03/17/2021

Event Type  Injury  

Event Description

It was reported that a revision hemiarthrosplasty was performed due to an unspecific infection.A pre-operative plan was made to debride as much of the infected tissue as possible and only remove and replace the tandem unipolar sleeve and head from the existing construct.

Manufacturer Narrative

The affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.A review of complaint history revealed no prior complaints for the listed batch and failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.A medical investigation was conducted and confirms per the provided complaint form, the sales rep.Provided the portion of the operative report that confirmed the unipolar head and sleeve punched off stem and the surgeon¿s debridement of the infected tissue and the removal and replacement of the tandem unipolar sleeve and head from the existing construct.However, per subsequent e-mail, no further clinical information will be provided.Consequently, without the requested clinical information, lab reports, x-ray, or the device the root cause of the reported infection cannot be determined.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this compliant will be re-assessed.A relationship, if any, between the device and the reported incident could not be corroborated.Infection, a potential complication associated with any surgery, can occur and 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.A review of risk management files and the instructions for use found that the probable cause failures were documented appropriately.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: TANDEM UNIPOLAR 51MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11689164
• MDR Text Key: 246229932
• Report Number: 1020279-2021-03206
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 03596010079800
• UDI-Public: 03596010079800
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 126651
• Device Catalogue Number: 126651
• Device Lot Number: 17GM05486
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention