MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-320

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 07/02/2020

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

It was reported that the patient had her hip replaced on (b)(6) 2020 by surgeon.I was notified the am of the surgery that the patient had an office visit with dr.(b)(6) upon her examination, it was determined that her hip was infected and an i&d as was to be done.During the procedure surgeon explanted all of the components she had implanted, did a thorough debridement and implanted a new summit pinnacle construct.Doi: (b)(6) 2020, dor: (b)(6) 2020, left side.

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.

• Brand Name: DELTA CER HEAD 12/14 32MM +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: 10278064
• MDR Text Key: 199067506
• Report Number: 1818910-2020-15936
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033448
• UDI-Public: 10603295033448
• 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: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1365-32-320
• Device Catalogue Number: 136532320
• Device Lot Number: 9318699
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 32IDX50OD; DELTA CER HEAD 12/14 32MM +5; PINNACLE SECTOR II CUP 50MM; SUMMIT POR TAPER SZ3 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR