MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +1; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-310

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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

This pc is created in order to capture additional event based on additional information received.It was reported that surgeon had revised the patient hip to a constrained liner.The patient primary hip had been done by another surgeon and she was seen in the er after her hip had dislocated.Doi: (b)(6) 2019, dor: (b)(6) 2020, right 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, post market surveillance, 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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DELTA CER HEAD 12/14 32MM +1
• 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: 11087084
• MDR Text Key: 224073884
• Report Number: 1818910-2020-27710
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033431
• UDI-Public: 10603295033431
• Combination Product (y/n): N
• PMA/PMN Number: K031803
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-32-310
• Device Catalogue Number: 136532310
• Device Lot Number: 8992970
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 32IDX50OD; ALTRX +4 10D 32IDX50OD
• Patient Outcome(s): Required Intervention