MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_4 CR FEMUR; KNEE IMPLANT

Catalog Number UNK_REC

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/26/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

The patient had a left total knee replacement (stryker triathlon primary total knee arthroplasty system) by dr.(b)(6) and is currently seeing him at different location.Patient states she has had constant pain since surgery, is unable to stand for long periods of time, has issues bending her knee and is experiencing some audible clicking.Patient states she is allergic to nickel and wants to know if the stryker devices contain any trace of nickel.She is currently suing a topical numbing cream (lidocaine and anti-inflammatory).

• Brand Name: UNKNOWN_4 CR FEMUR
• Type of Device: KNEE 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: 5514617
• MDR Text Key: 40830730
• Report Number: 0002249697-2016-00956
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2016
• 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: 67 YR
• Patient Weight: 73