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

Catalog Number 101154

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 09/26/2016

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing documentation and sterilization documentation for the devices in question revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event.

Event Description

The complaint involved a patient who underwent a hip revision surgery on (b)(6) 2016.The original surgery is dated (b)(6) 2003.The revision surgery occurred because of patient pain following a popping sensation.During the revision, the femoral stem, the modular neck and femoral head were revised to new non-omni components.

• Brand Name: OMNI HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONTRAINED
• Manufacturer (Section D): OMNILIFE SCIENCE, INC.; 480 paramount drive; raynham MA 02767
• Manufacturer (Section G): OMNILIFE SCIENCE, INC.; 480 paramount drive; raynham MA 02767
• Manufacturer Contact: edward cheal, phd. ; 480 paramount drive; raynham, MA 02676 ; 7742261813
• MDR Report Key: 6202221
• MDR Text Key: 63212704
• Report Number: 1226188-2016-00114
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2016

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 Expiration Date: 07/31/2006
• Device Catalogue Number: 101154
• Device Lot Number: 160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2001
• 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 Age: 65 YR