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

Model Number	510-1211
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device return anticipated but not yet received.
Event or Problem Description
Patient underwent total hip arthroplasty on (b)(6) 2018.Three weeks post-op, he went on vacation and "overdid it." upon experiencing pain, the doctor x-rayed and determined that the stem had rotated and become loose.A revision surgery was performed on (b)(6) 2019.
Additional Manufacturer Narrative
The evaluation revealed no new information over what was already included in the original submission.This follow up mdr is being submitted in order to close out the initial mdr report.

• Brand Name: ENTRADA
• Common Device Name: TOTAL HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 8586839
• Report Number: 1722511-2019-00008
• Device Sequence Number: 11336224
• Product Code: MEH
• UDI-Device Identifier: 00822409036226
• UDI-Public: (01)00822409036226(17)230712(10)A195573
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K171249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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: 07/12/2023
• Device Model Number: 510-1211
• Device Lot Number: A195573
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR