MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-320

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

Patient Problems Hematoma (1884); Ulcer (2274); No Code Available (3191)

Event Date 05/18/2020

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

Primary surgery (b)(6) 2009; with no issues until 5 months ago.Patient presented with a hematoma, has not reported any accident, illness.Dr has aspirated and multiple times.Nothing grown, to indicate infection.Patient having difficulty walking, and decided proceed with surgery.Ceramic head removed, nil marks.Surgeon reported the liner and cup to be well fixed and undamaged at time of incision, the wound was vascular, and blood was removed.The head was removed and replaced, to enable access to the hip joint.Doi: (b)(6) 2020.Dor: (b)(6) 2009.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Brand Name: DELTA CER HEAD 12/14 36MM +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: 10106371
• MDR Text Key: 193111208
• Report Number: 1818910-2020-12952
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033622
• UDI-Public: 10603295033622
• Combination Product (y/n): N
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1365-36-320
• Device Catalogue Number: 136536320
• Device Lot Number: 2940525
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; CORAIL2 NON COL HO SIZE 13; DELTA CER HEAD 12/14 36MM +5; DELTA CER INSERT 36ID X 56OD; PINN SECTOR HA ACET CUP 56MM; APEX HOLE ELIM POSITIVE STOP; CORAIL2 NON COL HO SIZE 13; DELTA CER HEAD 12/14 36MM +5; DELTA CER INSERT 36ID X 56OD; PINN SECTOR HA ACET CUP 56MM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR