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

Model Number	6495-2-040
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/28/2023
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat# 64813111; mrh tibial b/plt keel sml 2; lot# pdl2r.Cat# 5560-s-115; triathlon cemented stem-15mm x 50mm; lot# 1119762d.Cat# 64812100; mrh tib rot comp xs-xl; lot# 186078.Cat# 64812120; mrh axle; lot# ctd84293.Cat# 64812140; mrhk tibial sleeve; lot# ljh735.Cat# 64812110; mrhk femoral bushing; lot# lky384.Cat# 64813213; mrhk tib ins 13mm xs/s s1/s2; lot# ljh319.Cat# 64812130; mrhk bumper insert - neutral; lot# 64812130.Cat# 64812110; mrhk femoral bushing; lot# lke061.Cat# 6194-1-001; simplex hv us 1 pack; lot# 142ac919hc qty.2.Cat# 6194-1-001; simplex hv us 1 pack; lot# 122aa823bc.Cat# 6194-1-001; simplex hv us 1 pack; lot# 118aa820ac.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that the patient's right knee was revised.As reported: "patient revised due to patellar instability.No other information available due to hospital policy." a distal femoral component, rotating hinge, axle, bushings, bumper insert, tibial insert, baseplate, tibial sleeve, and stem were revised (rep confirmed patellar component was retained).
Event or Problem Description
It was reported that the patient's right knee was revised.As reported: "patient revised due to patellar instability.No other information available due to hospital policy." a distal femoral component, rotating hinge, axle, bushings, bumper insert, tibial insert, baseplate, tibial sleeve, and stem were revised (rep confirmed patellar component was retained).
Additional Manufacturer Narrative
Update to lot# of additional devices listed in this report: cat#: 64812130; mrhk bumper insert - neutral; lot#: lll716.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding instability involving an gmrs femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: "the event description from the product inquiry summary states: it was reported that the patient's right knee was revised.As reported: "patient revised due to patellar instability.No other information available due to hospital policy." a distal femoral component, rotating hinge, axle, bushings, bumper insert, tibial insert, baseplate, tibial sleeve, and stem were revised (rep confirmed patellar component was retained).The ap and lateral knee x-rays show a distal femoral replacing tka.The usage sheets from both on (b)(6) 2023, confirm implantation of a gmrs style distal femoral replacing knee.No information was provided as to the indication for the surgeries on (b)(6) 2023 was provided.Should further information become available i would be happy to further this assessment." device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: "the event description from the product inquiry summary states: it was reported that the patient's right knee was revised.As reported: "patient revised due to patellar instability.No other information available due to hospital policy." a distal femoral component, rotating hinge, axle, bushings, bumper insert, tibial insert, baseplate, tibial sleeve, and stem were revised (rep confirmed patellar component was retained).The ap and lateral knee x-rays show a distal femoral replacing tka.The usage sheets from both on (b)(6) 2023, confirm implantation of a gmrs style distal femoral replacing knee.No information was provided as to the indication for the surgeries on (b)(6) 2023 was provided.Should further information become available i would be happy to further this assessment." no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: GMRS DIST FEM COMP STD R 65MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17359498
• Report Number: 0002249697-2023-00799
• Device Sequence Number: 12393096
• Product Code: KRO
• UDI-Device Identifier: 07613327048780
• UDI-Public: 07613327048780
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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: 09/30/2026
• Device Model Number: 6495-2-040
• Device Catalogue Number: 64952040
• Device Lot Number: NC33N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male