MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 20MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-3-220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent right index tka outside cors scope.On (b)(6) 2021 patient presents with pain and is studied for infection.She is revised for pji on (b)(6) 2021.Liner and all rotating components were exchanged.Patient persists with infection and undergoes revision of right knee for pji on (b)(6) 2021.All components are exchanged.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation 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.Catalog numbers and lot codes of other devices listed in this report: 64812140 mrhk tibial sleeve lot lkm996, 64812100 mrh tib rot comp xs-xl lot 179063, 64812133 mrhk bumper insert 3 degrees lot lkr803, 64812120 mrh axle lot ctd50600, 64812110 mrhk femoral bushing lot lkn243 x 2, 64811101 mrh knee fem xs rht lot jsl3b, 64813110 mrh tibial b/plt keel sml 1 lot lxr9s, 5549-a-642 triathlonctrfemconeaug sz3&4r lot k1ej, 5549-a-120 triathlon sym cone aug sz b lot p9pp1, 5565-s-016 tri press-fit stem 16mm x 100mm lot 0081917a, 5565-s-010 tri press-fit stem 10mm x 100mm lot 0083056e, 64811200 mrhk fem distal blk 10mm xs lot jba2d, 64811200 mrhk fem distal blk 10mm xs lot j9x9a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: MRHK TIB INS 20MM 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13765620
• Report Number: 0002249697-2022-00387
• Device Sequence Number: 17096972
• Product Code: KRO
• UDI-Device Identifier: 07613327043839
• UDI-Public: 07613327043839
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

1 Device 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: 06/30/2026
• Device Model Number: 6481-3-220
• Device Catalogue Number: 64813220
• Device Lot Number: LKT056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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