MAUDE Adverse Event Report: STRYKER GMBH TIBIAL COMP,SINGLECOATED US VERSION, LARGE; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Model Number	400-263
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Numbness (2415); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.
Event or Problem 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: TIBIAL COMP,SINGLECOATED US VERSION, LARGE
• Common Device Name: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10564334
• Report Number: 0008031020-2020-02259
• Device Sequence Number: 2778928
• Product Code: NTG
• UDI-Device Identifier: 00886385016542
• UDI-Public: 00886385016542
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 400-263
• Device Catalogue Number: 400263
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Weight: 61