MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM XS LFT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-1-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); Subluxation (4525)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: mrhk tib ins 16mm xs/s s1/s2;64813216;ljc550.Mrh tibial b/plt keel sml 1;64813110;jce2h.Triathlonctrfemconeaug sz 5l;5549-a-651;kynl.Triathlon sym cone aug sz b;5549-a-120;em82.Tri press-fit stem 13mm x 100mm;5565-s-013;0083060m.Tri press-fit stem 18mm x 100mm;5565-s-018;0081933n.Mrhk fem distal blk 10mm xs;64811200;htx7a.Duracon tib wedge rt flt s1 5mm;6630-6-105;vr4ha.Mrhk tibial sleeve;64812140;ljs502.Mrh tib rot comp xs-xl;64812100;168183.Mrhk fem distal blk 10mm xs;64811200;ee72e.Duracon tib wedge lt flt s1 5mm;6630-6-125;bd74za.Mrh axle;64812120;unknown.Mrhk femoral bushing;64812110;lja144.Mrhk bumper insert 3 degrees;64812133;ljm743.Mrhk femoral bushing;64812110;ljl207.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 infection and periprosthetic fracture involving a mrh femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: visual , dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot and sterile lot.Conclusions: it was reported that the patient's left knee was revised due to infection and periprosthetic fracture.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op x- rays, patient history, pathology report & follow-up notes are needed to investigate this event further.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
This pi is for the (b)(6) 2020 revision.Patient underwent primary tka outside of cors scope.Had a revision tka on (b)(6) 2020 for pji.Patient had a fall plus subluxation of the patella, she also had symptoms of reinfection of the left knee.A revision was performed on (b)(6) 2020, a periprosthetic fracture b1 of the femur was observed, and maltraking of the patella.All components were exchanged except the tibial stem.

• Brand Name: MRH KNEE FEM XS LFT
• 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: 11375072
• Report Number: 0002249697-2021-00342
• Device Sequence Number: 3774317
• Product Code: KRO
• UDI-Device Identifier: 07613327045109
• UDI-Public: 07613327045109
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: 08/31/2024
• Device Model Number: 6481-1-100
• Device Catalogue Number: 64811100
• Device Lot Number: HP79J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/24/2021
• 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: 62 YR
• Patient Weight: 98