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 Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/09/2020

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

Clinical adverse event received for secondary septic arthritis, group b streptococcus bacteremia deep infection of the left hip, post left tha.Event is serious and is considered severe.Event is definitely related to both device and procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2020, (left hip).Treatment: hip revised on (b)(6) 2020, with i&d and exchange of head and liner.

Event Description

Medical records was received and reviewed: on (b)(6) 2009 ,right hip, depuy components, including depuy bone screw was used.No medical records provided for right hip.On (b)(6) 2020, the patient had a left hip arthroplasty to address secondary septic arthritis and pain.Depuy head/liner was implanted.

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, sterilization or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: b5.

• 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: 11065450
• MDR Text Key: 223410223
• Report Number: 1818910-2020-27628
• 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: health professional,study
• 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: 12/23/2020
• 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: 9483858
• 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: ACTIS COLLARED STD SIZE 5; ALTRX NEUT 32IDX50OD; PINNACLE SECTOR II CUP 50MM; ACTIS COLLARED STD SIZE 5; ALTRX NEUT 32IDX50OD; PINNACLE SECTOR II CUP 50MM
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 64