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

Catalog Number UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 06/17/2018

Event Type  Injury  

Event Description

It was reported that the patient suffered a dislocation in (b)(6) 2018 after a revision surgery of right total hip replacement on 2011.There is not any notification that a medical intervention or treatment was performed to correct the problem.

Manufacturer Narrative

The associated complaint devices were not returned.No product evaluation may be carried out.Without the device and no available device information, our investigation cannot proceed.If the device was returned or if new information is received in the future, this complaint can be re-opened.Based on this investigation, the need for corrective action is not indicated.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKNOWN
• 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 ; 1450 brooks road; memphis, TN 38116 ; 0110447940
• MDR Report Key: 7816677
• MDR Text Key: 118244100
• Report Number: 1020279-2018-01643
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/16/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2018
• 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): Other
• Patient Weight: 86