MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TIBIA; HIP IMPLANT

Catalog Number UNK_JR

Device Problems Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Injury (2348); Limited Mobility Of The Implanted Joint (2671)

Event Date 09/23/2016

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient underwent a left knee arthroplasty on (b)(6) 2012 and following the procedure continued to be in severe pain and limited in his mobility for several years.Subsequently on (b)(6) 2016 he underwent a revision due to "mechanical failure" by another surgeon who found that the parts used in the primary procedure were not acceptable or proper for use.The surgeon's medical record states "femur was a size 4 and the tibia was a size 8, which is not acceptable for this particular kind of implant, but was used.".

• Brand Name: UNKNOWN TIBIA
• Type of Device: HIP 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7435157
• MDR Text Key: 105634122
• Report Number: 0002249697-2018-01139
• Device Sequence Number: 1
• Product Code: MEH
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/16/2018
• 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): Hospitalization; Required Intervention