MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS EXTENSION PRICE 70MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6495-6-070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/17/2020
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.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
Patient fracture gets extension body.Update: "this was a left femur.The failure occurred on the extension body at the junction of the taper as you can see in these images.".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a gmrs extension was reported.The event was confirmed by attached images.Method & results: product evaluation and results: visual inspection of attached images was performed and stated that - gmrs extension piece seems to broke inside hmrs femoral component.Some blood marks also notable on extension piece surface.Dimensional, functional and material analysis inspection not performed as no product were returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: it was reported that the failure occurred on the left extension body at the junction of the taper.The event was confirmed by attached images.Visual inspection of attached images was performed and stated that - gmrs extension piece seems to broke inside hmrs femoral component.Some blood marks also notable on extension piece surface.The exact cause of the event could not be determined because of insufficient information.For example: further information such as pre- and post-operative x-rays 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 as no devices and / or insufficient information was received by stryker orthopedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
Event or Problem Description
Patient fracture gets extension body.Update: "this was a left femur.The failure occurred on the extension body at the junction of the taper as you can see in these images.".

• Brand Name: GMRS EXTENSION PRICE 70MM
• 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: 9711029
• Report Number: 0002249697-2020-00296
• Device Sequence Number: 19323837
• Product Code: KRO
• UDI-Device Identifier: 07613327049206
• UDI-Public: 07613327049206
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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: 10/31/2009
• Device Model Number: 6495-6-070
• Device Catalogue Number: 64956070
• Device Lot Number: LZYOD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/27/2020
• 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: 32 YR
• Patient Weight: 215