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

Catalog Number 136536320

Device Problem Fracture (1260)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.

Event Description

It was reported that the ceramic biolox was broken while impacting into corail stem.Surgery was delayed 5 minutes due to the reported event.Fragments were removed easily without additional intervention.

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 that 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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information was received and states that the stem was fine.It also states that another ceramic head was put.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: according to the information received."ceramic biolox has broken, while impacting into corail stem".The product was not returned to depuy synthes.However, photos were provided for review.Review of the photographic evidence confirmed, the reported allegation.The delta cer head 12/14 36mm +5, has fracture into three large fragments.No other defects were observed, on the provided evidence.With the provided information and the fact, that the femoral head was not returned for evaluation.Is not possible to determine, a potential cause at this moment, for the failure of the implant.A manufacturing record evaluation was performed, for the finished device#: [136536320, 4277021] number.And no non-conformances manufacturing irregularities related to the malfunction were identified, during manufacturing.The component properties and the microstructure as obtained from the quality documents fulfill the requirements, as specified at the time of production.There is no indication, of any pre-existing material defect.The overall complaint was confirmed.As the observed, condition of the delta cer head 12/14 36mm +5, would contribute to the complained device issue.Based on the investigation findings, it has been determined, that no corrective and/or preventative action is proposed.There is no indication, that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: protocols and certificate of conformance were reviewed.The quality documents show, that the data obtained on the femoral head conformed to the specification valid at the time of production.The component properties and the microstructure as obtained from the quality documents fulfill the requirements, as specified at the time of production.There is no indication, of any pre-existing material defect.Device history review: a manufacturing record evaluation was performed, for the finished device#: [136536320, 4277021] number.And no non-conformances manufacturing irregularities related to the malfunction were identified, during manufacturing.

• 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
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18387572
• MDR Text Key: 331492350
• Report Number: 1818910-2023-25902
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033622
• UDI-Public: 10603295033622
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P070026
• 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,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 136536320
• Device Lot Number: 4277021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2023
• 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