MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS 11MM X 127MM FEMORAL STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6485-3-011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.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.Device not returned.
Event or Problem Description
It has been reported "broken stem in situ".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mrs stem was reported.The event was confirmed via photos.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: device was shown with biological material throughout and the superior part of the device was fractured off confirming the event.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: one x-ray showing the top portion of the body as well as stem of a distal femoral replacing component.There are two hand drawn arrows purportedly pointing to a fracture in the distal portion of the stem.The x-ray picture is highly pixillated.I do not see any fracture in the stem nor the bony femur.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: the reported device was not returned however photographs were provided for review.The photographs note the following: device was shown with biological material throughout and the superior part of the device was fractured off confirming the event.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, and the primary 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.
Event or Problem Description
It has been reported "broken stem in situ.".

• Brand Name: MRS 11MM X 127MM FEMORAL STEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10626024
• Report Number: 0002249697-2020-02041
• Device Sequence Number: 3311865
• Product Code: LPH
• UDI-Device Identifier: 07613327048322
• UDI-Public: 07613327048322
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 10/31/2021
• Device Model Number: 6485-3-011
• Device Catalogue Number: 64853011
• Device Lot Number: 169244B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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: 22 YR