MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ARTICUL/EZE BALL 32 +9 BL; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-23-000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 02/11/2022

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

Procedure scheduled for total hip replacement with at (b)(6) clinic 7 am.The setup of the implants and instruments for the procedure is carried out, the planning is carried out with the specialist and it is reported that there is no news.Participation in the patient safety stop informing that there is no news from jj (implants and complete instruments).The specialist starts the procedure if there is no intra-surgical novelty.The procedure is completed without complications.We proceed to wash, organize and spend as used.Later, a call is received from the dr.Reporting that reviewing the patient's raio x; the insert does not match the femoral head.The doctor informs that on next day the patient will be operated on again.I review the photo of the consumption of the surgery that i have of the procedure and proceed to call the stock manager and confirm the expense.It is observed that implants of inadequate size were used between the insert with a diameter of 28 and the femoral head with a diameter of 32.The patient had to be operated on again, one day later, to change the femoral head.

Event Description

Reintervention of approximately 40 minutes.The operated hip was the left.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays and photographs were reviewed, and it can be observed that the liner does not match the femoral head.The complaint is confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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: ARTICUL/EZE BALL 32 +9 BL
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13938568
• MDR Text Key: 288104237
• Report Number: 1818910-2022-05727
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033196
• UDI-Public: 10603295033196
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1365-23-000
• Device Catalogue Number: 136523000
• Device Lot Number: D19101995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PINN MAR +4 10D 28IDX44OD
• Patient Outcome(s): Required Intervention