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

Catalog Number UNK_LIM

Device Problem Osseointegration Problem (3003)

Patient Problem Ambulation Difficulties (2544)

Event Date 07/21/2023

Event Type  Injury  

Event Description

A patient specific implant request for the patient's right tibia has the following noted: "aseptic loosening of right tibia endoprosthesis; history of giant cell tumor of bone.Patient has a right knee tibial rot comp - a straight cemented stem lot #185929b, a small proximal tibial component ¿ log 726984 lot 106954.Short tibia stem that has loosened.Would like to revise with a component that can an articulate with her femoral component but has a flange on the stem through which we can put screws to also engage the stem of the implant and the tibial cortex." planned date of surgery is (b)(6) 2023.Update per sales rep, "it is the tibial stem that has loosened.".

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Planned date of surgery is (b)(6) 2023.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

• Brand Name: UNKNOWN TIBIAL STEM
• 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: 17562839
• MDR Text Key: 321309199
• Report Number: 0002249697-2023-00902
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2023

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: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/17/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 102 KG