MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH D/M 10 IN SS BROAD COMP PLATE; PLATE, FIXATION, BONE

Catalog Number	3704-3-120
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/21/2019
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
On (b)(6) 2015 - gmrs distal femur.On (b)(6) 2017 - bipolar exeter.On (b)(6) 2017 - dall miles 9 hole plate and 6 cables used to fixed the periprosthetic fracture.Revision surgery needed because structure is not stable.Update 23/april/2019 wg: as reported in product not available, why not: revision surgery has not been scheduled.
Additional Manufacturer Narrative
An event regarding instability due to periprosthetic fracture involving a dall miles plate was reported.The event was confirmed by clinician review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: "undated x-ray confirms femoral fracture between knee and hip stem and failure of fracture fixation with dall miles cable plate; need additional information; primary and revision operative reports, clinical and past medical history, additional serial x-rays." 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: it was reported that revision surgery needed because structure is not stable.The provided x-ray confirms femoral fracture between knee and hip stem and failure of fracture fixation with dall miles cable plate.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 x-rays 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
(b)(6) 2015 - gmrs distal femur.(b)(6) 2017 - bipolar exeter.(b)(6) 2017 - dall miles 9 hole plate and 6 cables used to fixed the periprosthetic fracture.Revision surgery needed because structure is not stable.Update 23/april/2019 wg: as reported in product not available, why not: revision surgery has not been scheduled.*update 07/jun/2019 qs: based on the medical review statement: undated x-ray confirms femoral fracture between knee and hip stem and failure of fracture fixation with dall miles cable plate.

• Brand Name: D/M 10 IN SS BROAD COMP PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8617843
• Report Number: 0002249697-2019-01967
• Device Sequence Number: 16646874
• Product Code: HRS
• UDI-Device Identifier: 07613327036640
• UDI-Public: 07613327036640
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K922525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 01/31/2020
• Device Catalogue Number: 3704-3-120
• Device Lot Number: 50411204
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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: 76 YR