MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STAR POLYETHYLENE COMPONENT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the patient's attorney that allegedly following his left ankle replacement surgery, the patient began to experience increasing pain and decreased function in his ankle and presented back to the surgeon who identified a failure of the polyethylene component in his star ankle replacement system, causing him to suffer lateral impingement and tendon insufficiency.Allegedly he was referred to another surgeon who explained to the patient that his only viable options were to fuse the ankle or amputate the leg below the knee.It is further alleged on recommendation by the surgeon, he underwent a below-knee amputation on or about (b)(6) 2020.

• Brand Name: UNKNOWN STAR POLYETHYLENE COMPONENT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10478698
• MDR Text Key: 205268133
• Report Number: 0008031020-2020-02200
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050050
• 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: 09/01/2020

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: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/01/2020
• 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): Required Intervention; Disability