MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM L/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71343608

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 04/01/2020

Event Type  Injury  

Event Description

It was reported that the patient had fluid building up under his closed hip wound, following a thr.Additionally, the patient reported a feeling of small laxity in his soft tissues.The event was resolved via revision surgery, where the oxinium head was changed from a +8 to a +12.

• Brand Name: OXINIUM FEM HD 12/14 36 MM L/+8
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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 ; 0447940038
• MDR Report Key: 9919463
• MDR Text Key: 186328541
• Report Number: 1020279-2020-01130
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010477293
• UDI-Public: 03596010477293
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K022958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2020

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 Model Number: 71343608
• Device Catalogue Number: 71343608
• Device Lot Number: 19BM16418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2019
• 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