FDA Adverse Event Injury Summary report: N

VANTAGE

MDR report key: 8449368 · Received March 25, 2019

Report

Report Number: 1038671-2019-00178
Event Type: Injury
Date Received: March 25, 2019
Date of Event: December 17, 2018
Report Date: March 26, 2020
Manufacturer: EXACTECH, INC.
Product Code: HSN
PMA / PMN Number: K152217
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

SECTION H10: (A1) PATIENT IDENTIFIER: (B)(6). (A2) AGE AT THE TIME OF EVENT: 62 YEARS. (B2) ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED. (D4) SERIAL NUMBER: (B)(6), EXPIRATION DATE: 09-FEB-2028, UNIQUE IDENTIFIER (UDI) #: (B)(4). (G5) PMA/510(K)NUMBER: K152217. (H3) THE POTENTIAL LOOSENING REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, WHICH MAY HAVE LED TO ASEPTIC (NON-INFECTED) LOOSENING OF THE TIBIAL COMPONENT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT AVAILABLE FOR EVALUATION. (H4) DEVICE MANUFACTURE DATE: 12-FEB-2018. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (E3) HEALTH PROFESSIONAL?: SHOULD OF STATED YES. (G3) REPORT SOURCE: SHOULD OF BEEN HEALTH PROFESSIONAL ON INITIAL REPORT. NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): B6, B7, D7, D11, G8, H7, H9.

Additional Manufacturer Narrative · 1

PENDING EVALUATION.

Description of Event or Problem · 1

INDEX SURGERY: (B)(6) 2018. CONCERN FOR POSSIBLE TIBIAL COMPONENT LOOSENING NOTED AT 6 MONTH POST-OP VISIT. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
240391	VANTAGE	TIBIAL PLATE FB SZ 4 LT	HSN	EXACTECH, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Hospitalization\| R	UNK.