MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN STRYKER TOTAL KNEE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_JR

Device Problem Noise, Audible (3273)

Patient Problems Fall (1848); Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 09/21/2022

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.Device not returned.

Event Description

Right tka took place on (b)(6) 2022.Immediately following the procedure, the patient did not experience any pain and for 3 weeks had in-home physical therapy (pt).During the in-home pt, the patient achieved a rom of 110 degrees.However, shortly after, the patient slipped going down a stair and experienced pain for a few hours but no other issues.After this incident, the patient¿s rom started to decrease from 110 degrees to 108 and then to 104 and the patient began experiencing pain with bending.The patient continued pt from (b)(6) 2022 through (b)(6) 2022.During this time, the patient began experiencing increased pain, swelling, and a clicking/knocking sound.The swelling is primarily on the right side of the knee.The clicking/knocking occurs when the patient is walking and engaging in light exercise.The patient went in for a checkup in (b)(6), and was advised to return again in 3 weeks.The patient went in on (b)(6) 2022, at which point dr.Suggested a manipulation to increase range of motion.The manipulation occurred on (b)(6) 2022, with dr.Obtaining a range of motion of 150 degrees.After the manipulation, the patient achieved a rom of 135 degrees in pt.

• Brand Name: UNKNOWN STRYKER TOTAL KNEE
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16221501
• MDR Text Key: 307880288
• Report Number: 0002249697-2023-00058
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White