MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS AXIS PIN PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6366-9-220

Device Problems Material Erosion (1214); Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2022

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

Hmrs parts replacement after 12 years. The wear of the components was confirmed during the surgery. The parts have all been replaced as requested. Some poly parts were severely damaged or disassembled into individual parts due to the difficult disassembly. Due to wear and tear, it was suspected that replacing the components would be prudent.

• Brand Name: HMRS AXIS PIN
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13767288
• Report Number: 0002249697-2022-00395
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327049930
• UDI-Public: 07613327049930
• 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: Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/30/2013
• Device Model Number: 6366-9-220
• Device Catalogue Number: 63669220
• Device Lot Number: CTD145A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: KG
• Patient Outcome(s): Required Intervention; Hospitalization