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

Model Number	6481-3-213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a right tka outside cors scope in 2013, required an mua one month later.The patient developed pji with mssa and later with mrsa.Has been revised 5 times out of cors scope.In (b)(6) 2017 the patient is reimplanted, now entering cors registry.Patient develops again pji and instability.Patient undergoes resection and revision on (b)(6) 2021.Reported in cors per 7990knee covered in a separate report.Patient again presents with pji, so a resection arthroplasty is done on (b)(6) 2021, with plans of reimplantation later on.Pji persist, so patient is treated finally with an right knee arthrodesis on (b)(6) 2022.
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# 64811111; mrh knee fem s rgt; lot# jp26e, cat# 64813110; mrh tibial b/plt keel sml 1; lot# lnn9h, cat# 5560-s-215; triathlon cemented stem-15mm x 100mm; lot# 0105704d, cat# 5560-s-115; triathlon cemented stem-15mm x 50mm; lot# 0105701h, cat# 64812110; mrhk femoral bushing; lot# lkm975, cat# 64812100; mrh tib rot comp xs-xl; lot# 172881a, cat# 64812110; mrhk femoral bushing; lot# lkm031, cat# 64812133; mrhk bumper insert 3 degrees; lot# lkp580, cat# 64812120; mrh axle; lot# ctd54902, and cat# 64812140; mrhk tibial sleeve; lot# lkm729.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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# 64811111; mrh knee fem s rgt; lot# jp26e, cat# 64813110; mrh tibial b/plt keel sml 1; lot# lnn9h, cat# 5560-s-215; triathlon cemented stem-15mm x 100mm; lot# 0105704d, cat# 5560-s-115; triathlon cemented stem-15mm x 50mm; lot# 0105701h, cat# 64812110; mrhk femoral bushing; lot# lkm975, cat# 64812100; mrh tib rot comp xs-xl; lot# 172881a, cat# 64812110; mrhk femoral bushing; lot# lkm031, cat# 64812133; mrhk bumper insert 3 degrees; lot# lkp580, cat# 64812120; mrh axle; lot# ctd54902, and cat# 64812140; mrhk tibial sleeve; lot# lkm729.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient had a right tka outside cors scope in 2013, required an mua one month later.The patient developed pji with mssa and later with mrsa.Has been revised 5 times out of cors scope.In (b)(6) 2017 the patient is reimplanted, now entering cors registry.Patient develops again pji and instability.Patient undergoes resection and revision on (b)(6) 2021.Reported in cors per 7990knee covered in a separate report.Patient again presents with pji, so a resection arthroplasty is done on (b)(6) 2021, with plans of reimplantation later on.Pji persist, so patient is treated finally with an right knee arthrodesis on (b)(6) 2022.

• Brand Name: MRHK TIB INS 13MM XS/S S1/S2
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13598705
• Report Number: 0002249697-2022-00279
• Device Sequence Number: 1956364
• Product Code: KRO
• UDI-Device Identifier: 07613327043792
• UDI-Public: 07613327043792
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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: 03/31/2025
• Device Model Number: 6481-3-213
• Device Catalogue Number: 64813213
• Device Lot Number: LKA452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2020
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Race: Black Or African American