MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENDURANCE CALCAR SZ3 200MM; MISCELLANEOUS HIP STEM : HIP FEMORAL STEM

Model Number	1521-62-000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Pain (1994); Limb Fracture (4518)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that patient had a total left hip arthoplasty done (b)(6) 2021.("total hip package left femoral stem 12/14 taper endurance hip size 3 1521 62 000 depuy sna").The cement fell out("2/3rds of it from bottom up").End of stem gouging 2 notches inside femoral.Chronic pain.Rally my ab cement was used.Now they want to do it all over again, with no guarantee it won't happen again.Surgeon is very vague on his plan of attack, when asked if he is going to use a press in stem this time, or cemented.

• Brand Name: ENDURANCE CALCAR SZ3 200MM
• Common Device Name: MISCELLANEOUS HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16370749
• Report Number: 1818910-2023-03613
• Device Sequence Number: 15142967
• Product Code: JDI
• UDI-Device Identifier: 10603295057338
• UDI-Public: 10603295057338
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: 1521-62-000
• Device Catalogue Number: 152162000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown