MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. TIBIAL COMP,SINGLECOATED US VERS, X-LARGE; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Model Number	400-264
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/06/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.".
Event or Problem 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.".
Additional Manufacturer Narrative
Please note the correction to d2a.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 receieved indicating the kind of hardware failure.The only effective statement is an alleged non-union after approx.2 years of implantation.As to missing evidences a relation of reported accident in may 2016 to alleged 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.

• Brand Name: TIBIAL COMP,SINGLECOATED US VERS, X-LARGE
• Common Device Name: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; postfach; austin TX 78758 6313
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6775630
• Report Number: 0008031020-2017-00470
• Device Sequence Number: 16195805
• Product Code: NTG
• UDI-Device Identifier: 00886385016559
• UDI-Public: 00886385016559
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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 Expiration Date: 07/01/2018
• Device Model Number: 400-264
• Device Catalogue Number: 400264
• Device Lot Number: 130409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male