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

Catalog Number	HC-00070
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): OMNILIFE SCIENCE, INC.; 480 paramount drive; raynham MA 02767
• MDR Report Key: 8995048
• Report Number: 1226188-2019-00135
• Device Sequence Number: 2820115
• Product Code: LPH
• UDI-Device Identifier: 00841690100133
• UDI-Public: 00841690100133
• Combination Product (Y/N): N
• PMA/510(K) Number: K060072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: HC-00070
• Device Lot Number: 33035
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1