MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS DIST FEM COMP SML R 65MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6495-2-020
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: mrhk tib ins 10mm xs/s s1/s2, cat # 64813210, lot lfn797; mrh tibial b/plt keel sml 1, cat # 64813110, lot # bn76c ; mrh tib rot comp xs-x, cat # 64812100, lot # 103204; mrs fem stem w/o body 13x127mm, cat # 64853113, lot # 170938a; tri cemented stem 9mmx100mm, cat # 5560-s-209, lot # 0054319d; mrhk bumper insert 3 degrees, cat # 64812133, lot # lfh775; mrhk tibial sleeve, cat # 64812140, lot # lfg100; gmrs small axle, cat # 64952115, lot # ctd11486; gmrs small femoral bushing, cat # 64952105, lot # lfn299; gmrs small femoral bushing, cat # 64952105, lot # lfj936.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not available.
Event or Problem Description
Procedure: the patient had right knee replacement outside cors scope.Patient underwent right knee revision with distal femoral replacement (b)(6) 2017.Patient underwent revision of right distal femoral replacement for mechanical complication (b)(6) 2019.
Additional Manufacturer Narrative
Reported event: an event regarding revision due to reported mechanical complication involving a gmrs femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections 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 was rejected stating "cannot confirm event, need additional information; primary and readable 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: it was reported that the patient underwent revision of right distal femoral replacement for mechanical complication.The available medical records were provided to a consulting clinician for a review which was deemed insufficient to confirm the event.The event could not be confirmed nor the exact cause of the event be determined because insufficient information was provided.Further information such as more specific details around the reported event, return of the device, pathology reports, 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.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Procedure: the patient had right knee replacement outside cors scope.Patient underwent right knee revision with distal femoral replacement on (b)(6) 2017.Patient underwent revision of right distal femoral replacement for mechanical complication on (b)(6) 2019.

• Brand Name: GMRS DIST FEM COMP SML R 65MM
• 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: 9214549
• Report Number: 0002249697-2019-03563
• Device Sequence Number: 13998549
• Product Code: KRO
• UDI-Device Identifier: 07613327048759
• UDI-Public: 07613327048759
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 01/30/2020

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: 02/28/2022
• Device Model Number: 6495-2-020
• Device Catalogue Number: 64952020
• Device Lot Number: BRA3E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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: 71 YR
• Patient Weight: 126