MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number UNK_JR

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Arthritis (1723); Insufficient Information (4580)

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It was reported through stryker facebook page: "my mako knee lasted 8 weeks ! i had a revision a few years later!".

Event Description

Additional information was received indicating the reported devices were mako manufactured and not stryker joint replacement implants.A new initial mdr was submitted under mfr report # 3005985723-2024-00005 so that the correct manufacturer's registration number would be properly represented.All further information for this case will be processed under mfr report # 3005985723-2024-00005.It was reported through stryker facebook page: "my mako knee lasted 8 weeks ! i had a revision a few years later!".

Manufacturer Narrative

Additional information was received indicating the reported devices were mako manufactured and not stryker joint replacement implants.A new initial mdr was submitted under mfr report # 3005985723-2024-00005 so that the correct manufacturer's registration number would be properly represented.All further information for this case will be processed under mfr report # 3005985723-2024-00005.

• Brand Name: UNKNOWN_KNEE
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18138307
• MDR Text Key: 328107244
• Report Number: 0002249697-2023-01411
• Device Sequence Number: 1
• Product Code: MBH
• 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,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2024
• 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): Hospitalization; Required Intervention
• Patient Sex: Male