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

Catalog Number UNK_LIM

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

As reported: "pt.Presented with pain.Pt.Previously received an mrh stemmed-femur and gmrs proximal tibia replacement due to a tumor resection of the proximal tibia.X-ray films revealed the mrh stem in the femur canal broke at the stem/femur junction requiring revising of the femoral components.Dr.Revised the mrh femur to a gmrs distal femur construct.No previous surgery info was made available to us (dos, location, etc.), but based on measurements taken during the pre-op planning phase, the mrh femur was determined to be a ¿large¿ and the mrh stem a 14x80.The mrh insert s1/s2x10mm was replaced along with all the bushings, axle, tibial sleeve, and rotating component.Proximal tibia components were left in-situ." per rep: no allegations against the poly components or rotating component.Operative side: right.

• Brand Name: UNKNOWN LARGE MRH FEMUR
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12298832
• MDR Text Key: 265795031
• Report Number: 0002249697-2021-01339
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2021
• 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: 65 YR