MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 16MM MD/LG M2/L2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-3-316
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a mrh insert 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: no medical records were received for review with a clinical consultant.Product 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 lot or sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as 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.The following devices were also listed in this report: device name#mrhk tibial sleeve; cat#64812140; lot# ljx633.Device name#mrhk bumper insert - neutral; cat#64812130; lot#llc295.Device name#mrhk femoral bushing; cat#64812110; lot#lkt618.Device name#mrhk femoral bushing; cat# 64812110; lot#lkt618.Device name#mrh knee fem l rgt; cat#64811131; lot#lnp2d.Device name#ti dur reg fluted stem18x155mm; cat#64786725; lot#113809.Device name#mrhk fem distal blk 10mm l; cat#64811230; lot#ljn4c.Device name#mrh tibial b/plt keel med 2; cat#64813112; lot#nbb7h.Device name#ti dur reg fluted stem 16x80mm; cat# 64786630; lot#90235.Device name#triathlonasymconeaugsz c rm/ll; cat#5549-a-232; lot#h13n.Device name#mrh tib rot comp xs-xl; cat#64812100; lot#186034.Device name#mrh axle; cat#64812120;lot# ctd77391.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device not returned to the manufacturer.
Event or Problem Description
It was reported that the patient's right knee was revised.As reported: "this pt.Has been revised and ¿washed out¿ multiple times due to wound-healing issues.He received a ¿washout¿ and component-swap, along with the placement of antibiotic beads made from simplex cement and antibiotics.Requires another revision.No complaints filed against the components themselves." spoke to rep.Surgeon suspects infection as the patient's wound is not healing (reported cause is that the patient continues to smoke against medical advice).

• Brand Name: MRHK TIB INS 16MM MD/LG M2/L2
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17103256
• Report Number: 0002249697-2023-00657
• Device Sequence Number: 14970062
• Product Code: KRO
• UDI-Device Identifier: 07613327043853
• UDI-Public: 07613327043853
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• 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
• Report Date (Section B): 06/12/2023

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 Model Number: 6481-3-316
• Device Catalogue Number: 64813316
• Device Lot Number: LLD605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male