MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. UNKNOWN STAR IMPLANT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number UNK_SEL

Device Problems Break (1069); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Joint Laxity (4526); Implant Pain (4561); Insufficient Information (4580)

Event Date 06/20/2022

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported by the patient's attorney as a result of a legal claim that allegedly the patient was implanted with a scandinavian total ankle replacement (star) device.It is further alleged that he suffered personal injuries as a result of the implantation.

Manufacturer Narrative

Please note the corrections to b1, h6 device and h6 clinical signs codes.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event (such as the cat# and lot# of the device) as well as the affected device, and the patient information / activity levels must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported by the patient's attorney as a result of a legal claim that allegedly the patient was implanted with a scandinavian total ankle replacement (star) device.It is further alleged that he suffered personal injuries as a result of the implantation.Additional information: it was reported through the filing of a lawsuit that allegedly the patient was implanted with a stryker star ankle on (b)(6) 2014.Subsequently, the patient experienced progressive symptoms of pain and instability in his affected ankle.It is further alleged that the star implants polyethylene component material degraded causing it to fracture.

• Brand Name: UNKNOWN STAR IMPLANT
• 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: 15240177
• MDR Text Key: 298041518
• Report Number: 0001644408-2022-03007
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2022
• 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): Other
• Patient Sex: Male