MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-710

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 05/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised due to dislocation after undergoing left tha approximately 4 years ago.Cup screw head liner were removed.New cup liner head and screws placed.Doi: (b)(6) 2016.Dor: (b)(6) 2020; left hip.

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

• Brand Name: DLT TS CER HD 12/14 36MM +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10057039
• MDR Text Key: 190992771
• Report Number: 1818910-2020-12099
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033653
• UDI-Public: 10603295033653
• Combination Product (y/n): N
• PMA/PMN Number: K071830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-36-710
• Device Catalogue Number: 136536710
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 54MM; ALTRX +4 10D 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; PINN CAN BONE SCREW 6.5MM X 25MM; PINN SECTOR W/GRIPTION 54MM
• Patient Outcome(s): Required Intervention