MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +15.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136555000

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

Patient Problems Fall (1848); Ambulation Difficulties (2544); Physical Asymmetry (4573)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).E3: the initial reporter has been removed for confidentiality/privacy.The initial reporter is the patient.E3 initial reporter occupation: lawyer.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 patient had hip replacement failed and patient fell and then had emergency surgery for 6 hours.They had to break patient's femur to get the old one out.Patient's family were not calling a lawyer yet because they want to speak to someone regarding this.This happened on (b)(6) 2024.Hip replacement 2020 and revision due to leg discrepancy due was 2022.Doctor told that it was made by depuy.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary :no device associated with this report was received for examination.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 records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.Added: a1, a2, a3.

• Brand Name: ARTICULEZE M HEAD 36MM +15.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19153761
• MDR Text Key: 340725867
• Report Number: 1818910-2024-08736
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295033998
• UDI-Public: 10603295033998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136555000
• Device Lot Number: 9416621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2020
• 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: ALTRX NEUT 36IDX60OD.; CORAIL2 LAT COXA VARA SIZE 13.; PINN CAN BONE SCREW 6.5MMX35MM.; SECTOR PINNACLE GRIP 60 MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male