MAUDE Adverse Event Report: ORTHO DEVELOPMENT Tri-plus; TOTAL HIP PROSTHESIS

Model Number	138-3606
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient received total hip arthroplasty on (b)(6) 2019 and was revised on (b)(6) 2019 to replace the femoral head.Infection was reported as the reason for the revision.No further information was reported.The device was not returned for investigation.If additional information becomes available in the future, a follow-up report will be submitted.

• Brand Name: Tri-plus
• Common Device Name: TOTAL HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 9468133
• Report Number: 1722511-2019-00030
• Device Sequence Number: 17172510
• Product Code: LPH
• UDI-Device Identifier: 00822409016402
• UDI-Public: (01)00822409016402(17)231130(10)A205342
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K103384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 138-3606
• Device Lot Number: A205342
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR