MAUDE Adverse Event Report: OMNILIFE SCIENCE, INC. OMNI HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED

Catalog Number HC-00070

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2019

Event Type  malfunction  

Event Description

A complaint was initiated for an event involving a k1 stem missing its porous coating.After preliminary investigation and hhe assesment, a recall was initiated on (b)(6) 2019.

• Brand Name: OMNI HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): OMNILIFE SCIENCE, INC.; 480 paramount drive; raynham MA 02767
• Manufacturer Contact: 480 paramount drive; raynham, MA 02767
• MDR Report Key: 8995048
• MDR Text Key: 191542818
• Report Number: 1226188-2019-00135
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00841690100133
• UDI-Public: 00841690100133
• Combination Product (y/n): N
• PMA/PMN Number: K060072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HC-00070
• Device Lot Number: 33035
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2019
• 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