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

Model Number	130006
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint initially received on 9/21/2021.Recall in process of being processed.
Event or Problem Description
Complaint was initiated for the k2 stem surface finish.

• Brand Name: OMNI HIP SYSTEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): OMNI LIFE SCIECE, INC.; 480 paramount drive; raynham MA 02767
• MDR Report Key: 12579153
• Report Number: 1226188-2021-00125
• Device Sequence Number: 4289814
• Product Code: LPH
• UDI-Device Identifier: 00841690102496
• UDI-Public: 00841690102496
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K041950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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 Model Number: 130006
• Device Catalogue Number: 130006
• Device Lot Number: 38933
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 83 YR