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

Catalog Number 302899

Device Problem Naturally Worn (2988)

Patient Problem Arthralgia (2355)

Event Date 03/04/2014

Event Type  Injury  

Event Description

The complainant involved a patient who underwent hip revision surgery on (b)(6) 2014.The original surgery occurred on (b)(6) 2012.The surgery occurred as a result of wear of the cartilage of the acetabulum resulting in a revision to a tha.The original omni bipolar femoral head was replaced with an omni 38mm x +0mm femoral head cocr.

Manufacturer Narrative

The complainant made no indication of any omnilife science device malfunction or deficiency related to the identity, quality, durability, reliability, safety, effectiveness or device performance contributing to the adverse event.Review of the manufacturing and sterilization documentation for the explanted devices revealed no deviation from process or non-conformity of product that would have caused the adverse event.

• Brand Name: APEX HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): OMNLIFE SCIENCE, INC.; east taunton MA
• Manufacturer Contact: edward cheal ; 50 o'connell way; ste 10; east taunton, MA 02718 ; 7742261813
• MDR Report Key: 3763395
• MDR Text Key: 4551654
• Report Number: 1226188-2014-00021
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K082468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/14/2014

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 Catalogue Number: 302899
• Device Lot Number: 11641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2014
• Initial Date FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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: 73 YR
• Patient Weight: 84