MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE UHMPWE, 7MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400141

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.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event such as x-rays, patient information, as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

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: SLIDING CORE UHMPWE, 7MM
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10564336
• MDR Text Key: 208325928
• Report Number: 0008031020-2020-02257
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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 Expiration Date: 12/31/2016
• Device Catalogue Number: 400141
• Device Lot Number: 1015114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 61