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

Catalog Number UNK_REC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/23/2014

Event Type  Injury  

Event Description

It was reported that patient is experiencing pain and stiffness despite knee therapy-about 80 degrees of flexion.Spouse mentioned that the surgeon wants samples of the metal disc to test for metal sensitivity.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown left knee.An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.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: 4157286
• MDR Text Key: 4929299
• Report Number: 0002249697-2014-03803
• Device Sequence Number: 1
• Product Code: HRY
• 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: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• 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: 09/17/2014
• 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: 73 YR
• Patient Weight: 66