MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 46OD 26ID; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71325046

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/31/2020

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to pain, fever, swelling, and fracture.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A review of the device history records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical/medical team concluded: it was reported that revision surgery was performed 3 weeks post implantation, due to pain, fever, swelling, and fracture.It was additionally reported that the fracture was seen during the initial surgery.It was communicated via email that no medical records or x-rays will be provided, and the explanted devices will not be returned for analysis.Therefore, a clinical assessment cannot be performed and the patient impact beyond the revision surgery cannot be concluded.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TNDM BP SHL/XLPE LNR 46OD 26ID
• 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: 9687211
• MDR Text Key: 178371410
• Report Number: 1020279-2020-00501
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71325046
• Device Lot Number: 19GM21382
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention