MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS 11MM X 127MM FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6485-3-011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hip Fracture (2349); Ambulation or Postural Difficulties (2544)
Date of Event	09/10/2020
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
The following was reported: fracture of gmrs stem.
Event or Problem Description
The following was reported: fracture of gmrs stem.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mrs stem was reported.The event was confirmed by inspection of received image of device & clinician review.Method & results: product evaluation and results: the device was not returned.Visual inspection of the received image of the device noted that the device was fractured in two parts.Dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: the available medical records were provided to the consulting clinician for a review which noted," the event is confirmed.The x-ray shows a broken femoral stem at the bone/implant junction.Root cause: there is not enough clinical information to make an assessment of a root cause for the fracture of the stem.Obtaining medical records, and additional clinical and/or radiographic data may provide insight into the mechanism of failure.Examining the implant may also provide some insight.".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 were no other events for the lot provided.Conclusions: it was reported that stem was fractured.Visual inspection of the received image of the device noted that the device was fractured in two parts.The available medical records were provided to the consulting clinician for a review which noted that the event is confirmed.The x-ray shows a broken femoral stem at the bone/implant junction.There is not enough clinical information to make an assessment of a root cause for the fracture of the stem.Obtaining medical records, and additional clinical and/or radiographic data may provide insight into the mechanism of failure.Examining the implant may also provide some insight.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: MRS 11MM X 127MM FEMORAL STEM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10640741
• Report Number: 0002249697-2020-02060
• Device Sequence Number: 3321794
• Product Code: KRO
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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: 11/30/2021
• Device Model Number: 6485-3-011
• Device Catalogue Number: 64853011
• Device Lot Number: 169244E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 01/11/2021
• 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: 19 YR
• Patient Weight: 65