MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 132 SIZE 9 SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	1601-09132
Medical Device Problem Codes	Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Pain (1994); Hip Fracture (2349)
Date of Event	10/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Subject sustained a femoral fracture as a result of a fall on (b)(6) 2022.Orif was completed on (b)(6) 2022; see attached operative notes and attached clinic notes.Some concern of femoral subsidence; fracture healed as of (b)(6) 2024.(note that the operative note has a date of original surgery as 2017 which is incorrect.See subsequent follow-up clinic notes confirming original surgery as 2014.).Subject was enrolled in the secur-fit advance outcomes study 75.
Event or Problem Description
Subject sustained a femoral fracture as a result of a fall on (b)(6)2022.Orif was completed on (b)(6)2022; see attached operative notes and attached clinic notes.Some concern of femoral subsidence; fracture healed as of (b)(6)2024.(note that the operative note has a date of original surgery as 2017 which is incorrect.See subsequent follow-up clinic notes confirming original surgery as 2014.).Subject was enrolled in the secur-fit advance outcomes study 75.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a securfit stem was reported.A review of the provided medical records by a clinical consultant confirmed the event and also confirmed subsidence.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant stated the following: conclusion/assessment: the patient had a tha in 2014, the details of the surgery, preoperative care, postoperative care and postoperative course were not provided for review.The patient had an injury, a reported fall, in 2022 resulting in a periprosthetic femur fracture.The did not appear to be any traumatic injury to the acetabulum.The femur underwent orif with a plate and screws.The femoral component was felt stable even though the fracture extended up to the distal aspect of the prosthesis.The femoral component was not explored.No radiographs were provided for review.The postoperative course from the surgery was initially uneventful.But the patient continued to have thigh pain and pain that radiated to the knee which did have preexistent djd.The stem was reported to have subsided somewhat and developed a pedestal to indicating loosening.However, clinically there remained confusion as to whether the pain was coming all from the hip vs having contribution form the anthric knee.The knee underwent a series of steroid injections both for treatment and diagnostic purposes.Ultimately, it was felt that the stem had subsided and was contributing to the patient¿s thigh/knee pain.Revision surgery time slots were scheduled but continued conservative care undertaken and no revision performed as to the last record provided.Event confirmation: a periprosthetic femur fracture and orif can be confirmed.Healing of the fracture was documented.The stem was felt to have subsequently subsided.The injury was approximately 8 years after the initial tha and unrelated to the index surgery.Root cause: the root cause of the fracture and orif was a reported fall.The root cause of the subsidence would be the fracture.The events were unrelated to the index surgery performed approximately 8 years earlier.' -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been one other similar events for the lot referenced; (b)(4), relates to periprosthetic fracture for the same device and patient therefore no further trending is required for this commonality.Conclusions: a review of the provided medical records by a clinical consultant confirmed the event.' a periprosthetic femur fracture and orif can be confirmed.Healing of the fracture was documented.The stem was felt to have subsequently subsided.The injury was approximately 8 years after the initial tha and unrelated to the index surgery.Root cause: the root cause of the fracture and orif was a reported fall.The root cause of the subsidence would be the fracture.The events were unrelated to the index surgery performed approximately 8 years earlier.' if devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 132 SIZE 9 SECUR-FIT ADVANCED STEM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20897203
• Report Number: 0002249697-2024-01694
• Device Sequence Number: 9032806
• Product Code: LPH
• UDI-Device Identifier: 07613327021349
• UDI-Public: 07613327021349
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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 Expiration Date: 04/30/2019
• Device Catalogue Number: 1601-09132
• Device Lot Number: MNDV10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2014
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White