MAUDE Adverse Event Report: ORTHO DEVELOPMENT TRIBUTE; TOTAL HIP PROSTHESIS

Model Number	138-2200
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient experienced postoperative dislocation after bipolar hip arthroplasty.At the initial surgery on (b)(6) 2019, it was confirmed that the cup and head were firmly attached.Subsequent to the initial surgery, an x-ray determined that the head was dislocated from the cup and the cup was dislocated from the acetabulum.On (b)(6) 2019, the surgeon performed a revision to replace the cup and the femoral head.This report is two of two for this incident.

• Brand Name: TRIBUTE
• Common Device Name: TOTAL HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper, ut
• MDR Report Key: 10153524
• Report Number: 1722511-2020-00006
• Device Sequence Number: 19374057
• Product Code: LPH
• UDI-Device Identifier: 00822409016174
• UDI-Public: (01)00822409016174(17)231012(10)A201124
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

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: 10/12/2023
• Device Model Number: 138-2200
• Device Lot Number: A201124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1