MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 132 HIP STEM #9; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6051-0935S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Injury (2348)
Date of Event	03/03/2018
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 events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that patient's left hip was revised after patient fell in the hospital, sustaining a periprosthetic fracture of the trochanter of the femur.
Additional Manufacturer Narrative
An event regarding revision due to periprosthetic fracture involving a securfit stem was reported.The event was confirmed through medical review.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: a traumatic overload condition due to a reported fall has contributed to a periprosthetic fracture around the securefit max stem requiring revision.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated a traumatic overload condition due to a reported fall has contributed to a periprosthetic fracture around the securefit max stem requiring revision.It is reported that the stem was replaced with a restoration modular construct with a new v40 lfit femoral head and three cables to stabilize the fracture.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that patient's left hip was revised after patient fell in the hospital, sustaining a periprosthetic fracture of the trochanter of the femur.

• Brand Name: SECUR-FIT MAX 132 HIP STEM #9
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7374762
• Report Number: 0002249697-2018-00909
• Device Sequence Number: 1252251
• Product Code: LZO
• UDI-Device Identifier: 07613327021035
• UDI-Public: 07613327021035
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K051738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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: 03/31/2022
• Device Catalogue Number: 6051-0935S
• Device Lot Number: JE63RP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR