MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CEMENTED STEM SZ5 STD; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-03-110

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

Patient Problem Limb Fracture (4518)

Event Date 03/13/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.Component code: appropriate term/code not available (g07002) used to capture no findings available.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 Description

Patient was revised due to peri-prosthetic fracture around a depuy cemented hemi.There was no surgical delay.There was loosening reported at the bone/cement interface.Doi: (b)(6) 2023.Dor: (b)(6) 2023.Affected side: right hip.

• Brand Name: SUMMIT CEMENTED STEM SZ5 STD
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16627571
• MDR Text Key: 312125657
• Report Number: 1818910-2023-06713
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295059554
• UDI-Public: 10603295059554
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170339
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1570-03-110
• Device Catalogue Number: 157003110
• Device Lot Number: D22053017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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: ARTICUL/EZE BALL 28 +1.5 GR; CEMENTRALIZER 11.0; DEPUY SYNTHES CEMENT; SELF CENT HIP 44X28 GRY
• Patient Outcome(s): Required Intervention
• Patient Sex: Female