MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-019; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-1-019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Event occurred during conversion of a femoral nail to a left hemi hip.When impacting the cone body on to the distal stem, the patient's femur fractured.The stem construct was implanted and two cable and sleeve sets were added.Procedure completed successfully with a delay of approximately 10 minutes.
Additional Manufacturer Narrative
Reported event: an event regarding intraop fracture involving a restoration modular body was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that fracture of the femur occurred during impaction of the restoration modular cone body onto the stem and that the fracture was addressed intraoperatively.The exact cause of the event could not be determined because insufficient information was provided.Further information such as intra- and post-operative x-rays and the operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-019
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17114799
• Report Number: 0002249697-2023-00659
• Device Sequence Number: 7065749
• Product Code: LPH
• UDI-Device Identifier: 04546540641069
• UDI-Public: 04546540641069
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K013106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2023

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: 6276-1-019
• Device Catalogue Number: 6276-1-019
• Device Lot Number: 96172902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female