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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Fall (1848); Limb Fracture (4518)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional 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.
Additional 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 or Problem 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.

• Brand Name: SUMMIT POR TAPER SZ7 HI OFF
• Common Device Name: 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
• Report Number: 1818910-2022-14274
• Device Sequence Number: 17642933
• Product Code: LPH
• UDI-Device Identifier: 10603295060086
• UDI-Public: 10603295060086
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 07/21/2022; 08/22/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 08/04/2022; 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX +4 NEUT 36IDX58OD; ARTICULEZE M HEAD 36MM +8.5; PINNACLE SECTOR II CUP 58MM; SUMMIT POR TAPER SZ7 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White