MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ7 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-11-135

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

Patient Problems Cardiac Arrest (1762); Fall (1848); Limb Fracture (4518)

Event Date 07/11/2022

Event Type  Injury  

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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinical adverse event received for periprosthetic fracture (femoral).Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2022; date of event: (b)(6) 2022; (right hip).Treatment: revision (unknown components).

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.Replaced device revision replacement with additional information required.

Event Description

The patient had an orif right periprosthetic femur fracture, revision femoral component.The indication for surgery included: patient fell off ladder and had a periprosthtic femur fracture.An attempt to fix this approximately 48 hours ago, but upon induction of anesthesia, the patient had a significant cardiac event with hypertension that required resuscitation.The procedure had not started.Patient is now stabilized and was brought back to operating room to fix the fracture.It was noted that patient was already intubated and on a ventilator from icu (from the earlier cardiac issue that started during anesthesia previously).During the procedure the surgeon observed a long spiral fracture.Femoral stem appeared well fixed.The femoral head was replaced for a longer head for stability, due to the fracture.Synthese wires struts were used.

Manufacturer Narrative

Product complaint # : (b)(4).Additional information received indicates "patient sustained the periprosthetic fracture due to a fall off a ladder.This event is considered to be a trauma related incident (falling off ladder) and not a device related incident." it is reasonable to conclude that the device reported on this medwatch would not cause or contribute to the reported serious injury/revision as the revision is the consequence of trauma force.At this time depuy synthes joint reconstruction considers the device on this report to be not reportable.

• Brand Name: SUMMIT POR TAPER SZ7 HI OFF
• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15115750
• MDR Text Key: 296753618
• Report Number: 1818910-2022-14274
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060086
• UDI-Public: 10603295060086
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1570-11-135
• Device Catalogue Number: 157011135
• Device Lot Number: 3666788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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: ALTRX +4 NEUT 36IDX58OD; ARTICULEZE M HEAD 36MM +8.5; PINNACLE SECTOR II CUP 58MM; SUMMIT POR TAPER SZ7 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White