MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS FEM ROT HINGE RT 65MM BOD; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 2481-8-020

Device Problems Corroded (1131); Metal Shedding Debris (1804)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with reported discrepancies.There has been no other events for the lot referenced.An event regarding tibial loosening involving an mrs femoral component was reported.The material analysis report confirmed corrosion.Method & results: -device evaluation and results: material analysis of returned device was performed and indicated that debris was observed on the femoral component of the implant.Eds showed the femoral component was consistent with astm f75 alloy and the debris was consistent with a corrosion process and biological material.No material or manufacturing defects were observed on the surfaces examined.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: an event regarding tibial loosening involving an mrs femoral component was reported.The material analysis report was confirmed to corrosion.Material analysis of returned device was performed and indicated that debris was observed on the femoral component of the implant.Eds showed the femoral component was consistent with astm f75 alloy and the debris was consistent with a corrosion process and biological material.Further information such as pre- and post-op x-rays, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information become available, this investigation will be re-opened.

Event Description

Revision of mrs distal femoral replacement w/ all poly tibia for tibial loosening.Event update per review of the material analysis performed on (b)(6) 2017: "debris was observed on the femoral component of the implant.Eds showed the femoral component was consistent with astm f75 alloy and the debris was consistent with a corrosion process and biological material.No material or manufacturing defects were observed on the surfaces examined.".

• Brand Name: MRS FEM ROT HINGE RT 65MM BOD
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7204096
• MDR Text Key: 97707548
• Report Number: 0002249697-2018-00203
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2002
• Device Catalogue Number: 2481-8-020
• Device Lot Number: EUSVA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/1997
• 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: 30 YR
• Patient Weight: 52