MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM SHL/XLPE LNR 39OD26ID; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71325039

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

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 12/25/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to infection.

Manufacturer Narrative

The affected tandem shell/liner and oxinium femoral head were not returned for evaluation.A clinical analysis noted that no clinical relevant documentation was provided, therefore, a thorough medical investigation could not be performed.However, it was communicated that the revision surgery was performed due to infection.The patient impact beyond the reported revision for infection, probable antibiotic therapy, and an expected brief post-op convalescence period cannot be determined.No further medical assessment is warranted at this time.As device details were not made available, device history record review cannot be completed.Batch number was not provided, a sterilization review cannot be conducted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: TNDM SHL/XLPE LNR 39OD26ID
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8264164
• MDR Text Key: 133686605
• Report Number: 1020279-2019-00213
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• 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: 04/07/2019

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: 71325039
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/25/2018
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 12/25/2018
• Supplement Dates FDA Received: 04/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention