MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #2 RM/LL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 5630-G-228

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 09/08/2020

Event Type  Injury  

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.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.The following devices were also listed in this report: device name: triathlon pkr baseplate #2 rm/ll; cat#: 5620-b-202; lot#: brg9ba.Device name; triathlon pkr femur #3 rm/ll; cat#: 5610-f-302 ; lot#: a3v9u.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

It was reported that the patient's right knee was revised.As reported: "patient presented with ongoing pain/discomfort, ultimately requiring revision to a tka.No complaints have been filed against the implants." spoke to rep, who provided the primary and revision usage sheets, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIATHLON PKR INSERT X3 #2 RM/LL -8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 10618855
• MDR Text Key: 209546514
• Report Number: 0002249697-2020-02032
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 07613327015904
• UDI-Public: 07613327015904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082567
• 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: 10/02/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Model Number: 5630-G-228
• Device Catalogue Number: 5630-G-228
• Device Lot Number: X570J3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR