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

Catalog Number	H6-14836
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/17/2018, omni received notification from a sales representative through our complaint system that the patient stickers attached to the peel pack tyvek pouch did not match the outer box labeling.The outer box indicated a 0 degree hooded insert while the internal labeling indicated a 10 degree hooded insert.

• 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: 7546302
• Report Number: 1226188-2018-00084
• Device Sequence Number: 16187137
• Product Code: LPH
• UDI-Device Identifier: 00841690120315
• UDI-Public: 00841690120315
• Combination Product (Y/N): N
• PMA/510(K) Number: K101976
• 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): 05/17/2018

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 Expiration Date: 02/28/2023
• Device Catalogue Number: H6-14836
• Device Lot Number: 29778
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1