MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ASKU; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number ASKU

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 07/27/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was scheduled for (b)(6) 2018 to a patient due to have suffered continuous dislocations after had replacing the liner and the femoral head in 2011.

Manufacturer Narrative

The associated complaint devices were not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the devices or new information is received in the future, this complaint can be re-opened.The clinical / medical team also concluded that without the supporting clinically relevant documents, a thorough clinical investigation cannot be rendered.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: ASKU
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 101 hessle road; 101 hessle road; hull hu3 2bn, hull HU32B-N ; UK HU32BN
• MDR Report Key: 7816155
• MDR Text Key: 118221546
• Report Number: 1020279-2018-01638
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 86