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

Model Number	136-2800
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: TOTAL HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 12642667
• Report Number: 1722511-2021-00012
• Device Sequence Number: 1443156
• Product Code: LZO
• UDI-Device Identifier: 00822409034789
• UDI-Public: (01)00822409034789(17)250804(10)A240769
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111936
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2025
• Device Model Number: 136-2800
• Device Lot Number: A240769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR