FDA Adverse Event Injury Summary report: N

LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM

MDR report key: 15029794 · Received July 15, 2022

Report

Report Number: 1038671-2022-00799
Event Type: Injury
Date Received: July 15, 2022
Date of Event: August 30, 2017
Report Date: September 2, 2022
Manufacturer: EXACTECH, INC.
Product Code: JWH
UDI-DI: 10885862001849
PMA / PMN Number: K093360
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

PENDING EVALUATION. CONCOMITANT DEVICE(S): 02-010-01-0235: LOGIC FEMORAL PS CEM LEFT SZ 3.5, 02-012-45-3535: LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T, 200-02-32: THREE PEG PATELLA 32MM. FEMORAL STEM.

Additional Manufacturer Narrative · 0

SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF SURGICAL REVISION FOR INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

Description of Event or Problem · 0

AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY 8 MONTHS POST OP THE INITIAL LEFT TKA, THIS (B)(6) FEMALE PATIENT WAS REVISED DUE TO DEEP INFECTION. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1047756	LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	EXACTECH, INC.	02-012-35-3509	UNK	10885862001849

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR	Female	Required Intervention	SEE H10.