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	Fall (1848); Limb Fracture (4518)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical notification received for revision due to periprosthetic fracture.Date of implant: (b)(6) 2022.Date of revision: (b)(6) 2022.(right hip).Treatment: revision; head was removed.
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.
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.
Event or Problem Description
Patient received a right primary pinnacle/summit mop tha to treat end-stage osteoarthritis.The procedure was completed without complications.Patient received a right hip orif and head exchange to treat a periprosthetic femoral fracture sustained when he fell off a ladder two months after primary tha.Upon entering the joint, the surgeon identified a very long, spiral femoral fracture that was reduced with 3 synthes cables, 5 braided cables and fixation struts.The stem was well-ingrown, stable, and retained.The surgeon revised the femoral head with a longer neck to ensure stability of the hip and to reduce stress on the fracture as it healed.The procedure was completed without complications.
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.

• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15211527
• Report Number: 1818910-2022-15639
• Device Sequence Number: 4601623
• 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,Followup
• Report Date (Section B): 08/11/2022

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: 07/27/2022
• Supplement Date Received by Manufacturer: 08/04/2022; 08/24/2022; 08/24/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 08/23/2022; 08/24/2022; 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2017
• 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
• 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