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	09/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "pt.Presented with discomfort of the right knee.Dr.Determined his knee was infected.Dr.Performed an extensive i&d and swapped out all previous components listed on the 10/1 sheet for the components listed on the 9/2 sheet.No complaints filed against the implants themselves, no further info available.".
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: 64812130, mrhk bumper insert - neutral, lot: lkr796.64812110, mrhk femoral bushing, lot: lkm031.64812110, mrhk femoral bushing, lot: lkl431.64812140, mrhk tibial sleeve, lot: lkl792.64812120, mrh axle, lot : ctd50590.64812100, mrh tib rot comp xs-xl, lot: 177812a.64786625, ti dur reg fluted stem, 15x80mm lot: 0053742.64811111, mrh knee fem s rgt, lot: jpt9s.64786610, ti dur reg fluted stem, 12x80mm dhr lot: 0107964.64813112, mrh tibial b/plt keel med 2, lot: ly62c.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 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15475919
• Report Number: 0002249697-2022-01401
• Device Sequence Number: 12267171
• 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: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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: 06/30/2023
• Device Model Number: 6481-3-316
• Device Catalogue Number: 64813316
• Device Lot Number: LHN648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male