MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS PROX TIB REPL PART 142.5; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 6467-2-012

Device Problem Fracture (1260)

Patient Problems Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 08/10/2023

Event Type  Injury  

Event Description

It was reported that the patient exhibited clinical symptoms of instability.On surgical investigation, proximal tibial bore was found to be cracked.

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.H3 other text : device not returned.

Event Description

It was reported that the patient exhibited clinical symptoms of instability.On surgical investigation, proximal tibial bore was found to be cracked.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a hmrs tibial component was reported.The event was confirmed through evaluation of the provided photographs.Method & results: -product evaluation and results: the device was not returned however photographs were provided for review.The photographs show recently explanted devices covered in blood and the tibial bore is fractured.-medical records received and evaluation: a review of medical records with a clinical consultant indicated the following "conclusion/assessment: the pi report notes failure of a tibial bore.The x-ray shows significant angulation of a linked hinge component.There appears to be failure of the hinge mechanism.The specifics of which cannot be defined without additional information and medical records.Event confirmation: the event cannot be confirmed without additional medical records.Root cause: a root cause cannot be ascertained as the event cannot be confirmed.If in fact failure of the linkage piece of the hinge was confirmed, it would be the source of the instability and revision." -device history review: product history review could not be performed due to insufficient information.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the device was not returned however photographs were provided for review.The photographs show recently explanted devices covered in blood and the tibial bore is fractured.A review of medical records with a clinical consultant indicated the following "conclusion/assessment: the pi report notes failure of a tibial bore.The x-ray shows significant angulation of a linked hinge component.There appears to be failure of the hinge mechanism.The specifics of which cannot be defined without additional information and medical records.Event confirmation: the event cannot be confirmed without additional medical records.Root cause: a root cause cannot be ascertained as the event cannot be confirmed.If in fact failure of the linkage piece of the hinge was confirmed, it would be the source of the instability and revision.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: HMRS PROX TIB REPL PART 142.5
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17698048
• MDR Text Key: 322820528
• Report Number: 0002249697-2023-00998
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

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: Health Professional
• Device Catalogue Number: 6467-2-012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 02/05/2024
• 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 Age: 51 YR
• Patient Sex: Male