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

Catalog Number	64813316
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection involving an mrh insert was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as product was not returned medical records received and evaluation: no medical records were received for review with a clinical consultant product history review: all 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.There have been no other similar events for the reported sterile lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, pathology report, progress notes, x-rays 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.The following devices were also listed in this report: mrh tibial b/plt keel med 2; cat# 64813112; lot# emtlh; triathlon asym patella a35x10; cat# 5551l350; lot# ler883; mrh tib rot comp xs-xl; cat# 64812100; lot# 079498; tri press-fit stem 16mm x 100mm; cat# 5565-s-016; lot# 0039694e; mrs fem stem w/o body 17x127mm; cat# 64853117; lot# 124111a; med howmedica bone plug 1pk; cat# 6215-5-011; lot# cppph07bc; mrh axle; cat# 64812120; lot# ctd8667; mrhk tibial sleeve; cat# 64812140; lot# lel632; mrhk femoral bushing; cat# 64812110; lot# lek854; mrhk femoral bushing; cat# 64812110; lot# lez170; mrhk bumper insert - neutral; cat# 64 812130; lot# ldw762; triathlon sym cone aug sz d; cat# 5549-a-140; lot# a84h; gmrs dist fem comp std r 65mm; cat# 64952040; lot# eassy.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned to the manufacturer.
Event or Problem Description
As reported: "procedure: the patient underwent right total knee arthroplasty on (b)(6) 2016.Patient fell and sustained femur fracture.Patient underwent removal of hardware with right knee revision.Patella was retained, all other components were exchanged on (b)(6) 2016.Right knee then got infected after knee revision regarding fracture revision.Patient underwent revision for pji on (b)(6) 2018.All components (fixed and rotating) except femur were exchanged".

• 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
• MDR Report Key: 7969799
• Report Number: 0002249697-2018-03380
• Device Sequence Number: 1255584
• Product Code: KRO
• UDI-Device Identifier: 07613327043853
• UDI-Public: 07613327043853
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2018

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: 11/30/2019
• Device Catalogue Number: 64813316
• Device Lot Number: LEA457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/16/2018
• 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: 86 YR
• Patient Weight: 102