MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-330

Device Problem Wrong Label (4073)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2023

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2023, that surgeon asked for a 36 + 5 ceramic head during a total hip replacement surgery.A sales representative verbally confirmed product contents from outer box and handed a sealed/closed box to nurse.The nurse opened the box, removed the implant stickers, and discovered they were 36 +8.5, not 36 +5 as the box described.The implant was not opened, and instead another 36 +5 box was opened after contents were confirmed to be a match with the box description.No surgical delay.This report is for delta cer head 12/14 36mm +8.5 this is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint #
=
>(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device found that the patient and carton labels for the packaged ceramic head did not match; different product codes and lot numbers were observed.However, the reported complaint condition cannot be traced to a manufacturing issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot :a manufacturing record evaluation was performed for the finished device [136536330 / 3999262] and [136536320 / 4151745], and no non-conformances / manufacturing irregularities were identified during manufacturing.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DELTA CER HEAD 12/14 36MM +8.5
• 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
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17194709
• MDR Text Key: 318013404
• Report Number: 1818910-2023-12907
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033639
• UDI-Public: (01)10603295033639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-36-330
• Device Catalogue Number: 136536330
• Device Lot Number: 3999262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 06/27/2023; 08/11/2023
• Supplement Dates FDA Received: 06/28/2023; 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 36MM +5.
• Patient Age: 75 YR
• Patient Sex: Female