MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 13MM M/L M2/L2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6481-3-313

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Fall (1848)

Event Date 11/04/2021

Event Type  Injury  

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.The following devices were also listed in this report: mrh tib rot comp xs-xl; cat#64812100 ; lot#180632a, mrh hdp assembly pack; cat#64812150 ; lot#lkh870, mrh axle; cat#64812120 ; lot#ctd59698, mrhk bumper insert 3 degrees ; cat#64812133 ; lot# lkn513.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.

Event Description

As reported: "patient fell and opened part of the incision.Dr.Changed out components just as a precaution.No damage was done to the implants." left knee.An mrh tibial rotating component, mrh tibial insert, mrh bushings, mrh knee bumper insert, and modular rotating hinge were swapped for the same components.

• Brand Name: MRHK TIB INS 13MM M/L M2/L2
• Type of Device: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12907181
• MDR Text Key: 281498908
• Report Number: 0002249697-2021-01987
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327043846
• UDI-Public: 07613327043846
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6481-3-313
• Device Catalogue Number: 64813313
• Device Lot Number: LKM170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 139 KG