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

Model Number 400-142F

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 10/28/2022

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Cannot be returned due to hospital policy.

Event Description

It was reported that a poly swap took place on (b)(6) 2022 due to an incisional breakdown and soft tissue dehiscence.The surgeon reported that there was no failure of the device.The surgeon decided to remove the 8mm poly (400-142f lot : 2127040) and replaced it with an 7mm ( 400-141f lot : 2013257) poly instead due a clean up of an independent infection causing a smaller space at the surgical site.

Event Description

It was reported that a poly swap took place on (b)(6) 2022 due to an incisional breakdown and soft tissue dehiscence.The surgeon reported that there was no failure of the device.The surgeon decided to remove the 8mm poly (400-142f lot: 2127040) and replaced it with an 7mm ( 400-141f lot: 2013257) poly instead due a clean up of an independent infection causing a smaller space at the surgical site.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned and no additional information was available.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.

• Brand Name: SLIDING CORE, UHMPWE,8MM
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; 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: 15875511
• MDR Text Key: 304415997
• Report Number: 0001644408-2022-03023
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: 00886385026947
• UDI-Public: 00886385026947
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 400-142F
• Device Catalogue Number: 400142F
• Device Lot Number: 2127040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• 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 Age: 72 YR
• Patient Sex: Male