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 Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 04/01/2020

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

Surgeon is reporting a revision of an unknown pinnacle inlay unknown side because of fracture of inlay.A surgical delay was not reported.Doi: (b)(6) 2017.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.

• 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: 10232861
• MDR Text Key: 197572223
• Report Number: 1818910-2020-14979
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 1365-32-320
• Device Catalogue Number: 136532320
• Device Lot Number: 8437598
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 10; DELTA CER HEAD 12/14 32MM +5; PINN MAR +4 10D 32IDX48OD; PINNACLE 100 ACET CUP 48MM; APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 10; DELTA CER HEAD 12/14 32MM +5; PINN MAR +4 10D 32IDX48OD; PINNACLE 100 ACET CUP 48MM
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 96