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

Catalog Number HC-22004

Device Problems Metal Shedding Debris (1804); Device Contamination with Chemical or Other Material (2944)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 08/19/2014

Event Type  Injury  

Event Description

The complaint involved a patient who underwent hip revision surgery in (b)(6) 2014.The original surgery was on (b)(6) 2012.The revision surgery occurred as a result of chronic pain and elevated metal ion levels.An arc stem, size 3 and an anteverted arc neck were revised to a modular femoral neck with locking bolt and a 5x13mm porous femoral stem.Intra-operative photographs of the explanted neck indicated a small amount of black debris at the neck-stem junction.

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 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: matthew nowland ; 50 o'connell way, suite 10; east taunton, MA 02718 ; 7742261841
• MDR Report Key: 4122367
• MDR Text Key: 4792166
• Report Number: 1226188-2014-00056
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K111193
• 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: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: HC-22004
• Device Lot Number: 11466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• 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: 72 YR
• Patient Weight: 95