MAUDE Adverse Event Report: STRYKER GMBH TALAR COMP,SINGLE COATED US VERSION SMALL, RIGHT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Model Number 400-254

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

Patient Problems Numbness (2415); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.

Event Description

Patient had right ankle surgery done on (b)(6) 2013.Patient stated that approx in 2016 she felt as if she had broken her ankle again.Patient has been experiencing stabbing pain, cannot put weight on her ankle, swelling, her alignment is off balance, soreness on her lower back, ankle feels hot, instability, numbness in the back of her heel and she now has a clicking sound.Patient stated the pain will wake her during the night.Patient cannot wear shoes due to the swelling.The patient stated that this has affected her knees and has been told that she is now a candidate for knee replacement.Patient takes tramadol for her pain.Patient has had physical therapy on a yearly basis to the maximum allowed by her insurance.

• Brand Name: TALAR COMP,SINGLE COATED US VERSION SMALL, RIGHT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10564335
• MDR Text Key: 208198555
• Report Number: 0008031020-2020-02258
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: 00886385016450
• UDI-Public: 00886385016450
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 400-254
• Device Catalogue Number: 400254
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• 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): Other
• Patient Age: 54 YR
• Patient Weight: 61