MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 132 HIP STEM #11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6051-1140S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Hip Fracture (2349)
Date of Event	03/09/2019
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.Device not returned.
Event or Problem Description
It was reported that the patient's right hip was revised.Patient felt a pop in her hip with temporary pain which subsided.X-rays showed the existence of a femoral periprosthetic fracture.A securfit max stem and biolox ceramic head were revised to a restoration modular stem construct and another stryker femoral head, and 4 sets of cables.Rep provided pre- and post-revision x-rays and the primary implant sheet and reported that the no further information will be released.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture and subsidence involving a securfit stem was reported.The event was confirmed based on review of the provided x-rays.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections 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: x-ray confirms periprosthetic fracture with stem subsidence., need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: while the event was confirmed based on review of the provided x-rays, the exact cause of the event could not be determined because insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components 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.
Event or Problem Description
It was reported that the patient's right hip was revised.Patient felt a pop in her hip with temporary pain which subsided.X-rays showed the existence of a femoral periprosthetic fracture.A securfit max stem and biolox ceramic head were revised to a restoration modular stem construct and another stryker femoral head, and 4 sets of cables.Rep provided pre- and post-revision x-rays and the primary implant sheet and reported that the no further information will be released.

• Brand Name: SECUR-FIT MAX 132 HIP STEM #11
• 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: 8486683
• Report Number: 0002249697-2019-01550
• Device Sequence Number: 16773156
• Product Code: LZO
• UDI-Device Identifier: 07613327021059
• UDI-Public: 07613327021059
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K051738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 01/31/2021
• Device Catalogue Number: 6051-1140S
• Device Lot Number: 8D7AWH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 11/14/2019
• 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: 62 YR