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

Catalog Number UNK_REC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 12/13/2013

Event Type  Injury  

Event Description

Knee replaced with a 13 degree error.Request technical information on a replacement rotary arc insert for a primary knee replacement, with a 13 degree correction.I can provide x-rays if further details are required.As a professional engineer, i believe these replacements can be manufactured.Additional information: after implantation of right knee, patient is experiencing pain.Patient said based on x-ray, the device was implanted wrong.He was advised by doctor to have a revision done.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown stryker right knee.An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4295537
• MDR Text Key: 5270162
• Report Number: 0002249697-2014-04513
• Device Sequence Number: 1
• Product Code: KWY
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• 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
• Date Manufacturer Received: 11/10/2014
• 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: 50 YR
• Patient Weight: 68