MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. SLIDING CORE UHMPWE, 8MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400142

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Injury (2348); Non-union Bone Fracture (2369)

Event Date 05/06/2016

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker 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.Device is not available.

Event Description

It was reported through the filing of a lawsuit that allegedly on (b)(6) 2014 the patient underwent a total left ankle replacement surgery.It is alleged that on (b)(6) 2015 he twisted his left ankle and on (b)(6) 2016 the implant caused injury to the patient due to ".Hardware failure involving the medial aspect of the ankle joint, failed tibial component resulting in failed hardware with medial malleol or non union requiring a revision and removal of said product.".

Manufacturer Narrative

The reported event that non-union occurred could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidence were provided for investigation.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.It was alleged that on (b)(6) 2014 the patient underwent a total left ankle replacement surgery.It is alleged that on (b)(6) 2015 he twisted his left ankle and on (b)(6) 2016 the implant caused injury to the patient due to ".Hardware failure involving the medial aspect of the ankle joint, failed tibial component resulting in failed hardware with medial malleol or non union requiring a revision and removal of said product." no essential medical records were received indicating the kind of hardware failure.The only effective statement is an alleged non-union after apprpx 2 years of implantation.As to missing evidences a relation of reported accident in (b)(6) 2016 to alledged non-union could not be verified.With available information it could not be determined if the product had suffered from the alleged incident.Basically a non union refers to patient factors and is not primarily associated with a product deficiency.In this case a real caused could not be identified.If the device is returned or if any additional information, like medical documents, is provided, the investigation will be reassessed.

Event Description

It was reported through the filing of a lawsuit that allegedly on (b)(6) 2014 the patient underwent a total left ankle replacement surgery.It is alleged that on (b)(6) 2015 he twisted his left ankle and on (b)(6) 2016 the implant caused injury to the patient due to ".Hardware failure involving the medial aspect of the ankle joint, failed tibial component resulting in failed hardware with medial malleol or non union requiring a revision and removal of said product.".

• Brand Name: SLIDING CORE UHMPWE, 8MM
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; postfach; austin TX 78758 6313
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; postfach; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6775642
• MDR Text Key: 82107888
• Report Number: 0008031020-2017-00472
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 400142
• Device Lot Number: 1311203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2022
• 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
• Patient Sex: Male