MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS BEARING - 18 X 24 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6465-6-018

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problem Ambulation Difficulties (2544)

Event Date 03/18/2022

Event Type  Injury  

Event Description

The following was reported: revision (hmrs parts replacement). After 23 years, the poly is worn out. It is manifested by hyperextension of the knee joint and marked instability. The distal femur shows signs of wear, which shows up as metallosis in the knee joint. "now after the revision surgery everything was fine again. ".

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.

• Brand Name: HMRS BEARING - 18 X 24
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14073858
• MDR Text Key: 288994391
• Report Number: 0002249697-2022-00510
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 6465-6-018
• Device Catalogue Number: 64656018
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• 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 Treatment Data

Date Received: 04/11/2022 Patient Sequence Number: 1