MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX FORTE US HEAD 36MM S/+0 12/14TPR; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71332084

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 08/27/2018

Event Type  Injury  

Event Description

It was reported a serious injury in which patient was complaining of pain.It was found that the ceramic liner was not fractured, implants were fine.Surgeon changed liner to a poly liner and a new femoral head was put on.No issues, no delays, no injuries.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: BIOLOX FORTE US HEAD 36MM S/+0 12/14TPR
• 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: 7896285
• MDR Text Key: 120961873
• Report Number: 1020279-2018-01865
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 00885556019849
• UDI-Public: 00885556019849
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71332084
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention