MAUDE Adverse Event Report: ORTHO DEVELOPMENT DELTA CERAMIC FEMORAL HEAD; TOTAL HIP PROSTHESIS

Model Number 136-2800

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Arthralgia (2355)

Event Date 07/23/2021

Event Type  Injury  

Event Description

Two months after a total hip replacement, the patient fell then subsequently complained of pain.A dislocation of the femoral head from the cup was diagnosed.The surgeon performed a dislocation tourniquet and replaced the femoral head leaving the cup and liner in place.

• Brand Name: DELTA CERAMIC FEMORAL HEAD
• Type of Device: TOTAL HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 12642667
• MDR Text Key: 276841345
• Report Number: 1722511-2021-00012
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00822409034789
• UDI-Public: (01)00822409034789(17)250804(10)A240769
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/30/2021

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
• Device Operator: Health Professional
• Device Model Number: 136-2800
• Device Lot Number: A240769
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR