MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 13MM XS/S S1/S2; KNEE JOINT FEMOROTIBIAL METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	64813213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Injury (2348)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: ti dur reg fluted stem16x155mm; cat# 64786715; lot# 0029787, ti dur reg fluted stem 15x80mm; cat# 64786625; lot# 0059413, mrh tibial b/plt keel sml 2; cat# 64813111; lot# hra4s, mrh knee fem s rgt; cat# 64811111; lot# e6s9b, triathlon sym cone aug sz b; cat# 5549-a-120; lot# h3ej, mrhk tibial sleeve; cat# 64812140; lot# ljh733, mrh axle; cat# 64812120; lot# ctd36391, mrh tib rot comp xs-xl; cat# 64812100; lot# 154801, mrhk bumper insert - neutral; cat# 64812130; lot# lhb462, mrhk femoral bushing; cat# 64812110; lot# ljb111, mrhk femoral bushing; cat# 64812110; lot# ljb114, triathlon asymmetric x3 patella; cat# 5551-g-320; lot# 452y.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding infection involving an mrh insert 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: "re pi - which represents a female patient, dob (b)(6) described as 72 inches tall and weighing (b)(6) pounds.Event description states:.Cellulitis of right lower extremity.Removal of right total knee.All components.¿ date of implant (b)(6) 2019.Date of explanation (b)(6) 2019.Listed multiple components for modular mrh hinged tka with femoral and tibial stems.X-ray printout dated (b)(6) 2019 are 2 ap views of the right knee demonstrating a modular long stemmed , hinged tka which is reduced in nominal position with the patella not visualized.No pathology is demonstrated.No operative reports, no clinical or past medical history, no laboratory data or examination of explanted components.Based upon the information available for review, no confirmation of the event description or creation of a report is possible." device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: no other similar events were reported for the lot or sterile lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, operative reports, progress notes, clinical or past medical history, laboratory data or examination of explanted components and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Infection is a known possible adverse outcome of surgery, as noted in the instructions for use.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.When the sterile barrier of any device is opened, the sterility of that device becomes a function of handling and surgical technique and is beyond stryker¿s control.Infection due to bacterial contamination, as supplied from the manufacturer, is an extremely rare event.
Event or Problem Description
As reported: "pre-op diagnosis: cellulitis of right lower extremity.Procedure: removal of right total knee.Removed: all components.No further information available.".

• Brand Name: MRHK TIB INS 13MM XS/S S1/S2
• Common Device Name: KNEE JOINT FEMOROTIBIAL METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9592965
• Report Number: 0002249697-2020-00105
• Device Sequence Number: 18947024
• Product Code: KRO
• UDI-Device Identifier: 07613327043792
• UDI-Public: 07613327043792
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2020

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: 02/28/2023
• Device Catalogue Number: 64813213
• Device Lot Number: LHH829
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/15/2020
• 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: 58 YR
• Patient Weight: 118