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

Model Number	510-0213
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A total hip arthroplasty was performed on (b)(6) 2021.During postoperative x-ray, the hip dislocated and manipulation was insufficient to restore the joint.The incision was reopened, the stem removed, and additional broaching was performed.In the end, the surgeon replaced the stem with a different model to reduce the potential for dislocation.The surgeon indicated this was not a product issue.

• 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: 11408303
• Report Number: 1722511-2021-00006
• Device Sequence Number: 4274979
• Product Code: MEH
• UDI-Device Identifier: 00822409035984
• UDI-Public: (01)00822409035984(17)250810(10)A241018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2021

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: 08/10/2025
• Device Model Number: 510-0213
• Device Lot Number: A241018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR