MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problems Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)

Patient Problems Swelling (2091); Complaint, Ill-Defined (2331); Osteolysis (2377); Foreign Body In Patient (2687)

Event Date 02/28/2014

Event Type  Injury  

Event Description

About 6 years ago, the patient underwent tka with scorpio nrg for condylar necrosis.Maximam flection angle was 140°.About 4 years ago ((b)(6) 2012), swelling and radiolucent line were confirmed.Also, foreign particle was confirmed by arthrocentesis.But, it was not possible to specify the material of the foreign particle.The patient had no pain.On (b)(6) 2014, there are sinking of the tibial baseplate and radiolucent line.The surgeon has to decide on courses of treatment for swelling and bone destruction.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown series 7000 reduced keel tibia.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Device remains implanted.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: IMPLANT
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3878133
• MDR Text Key: 15329316
• Report Number: 0002249697-2014-02330
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2014
• 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): Other
• Patient Age: 66 YR