FDA Adverse Event Injury Summary report: N

THREE PEG PATELLA 32MM

MDR report key: 13012599 · Received December 15, 2021

Report

Report Number: 1038671-2021-00709
Event Type: Injury
Date Received: December 15, 2021
Date of Event: November 24, 2021
Report Date: June 23, 2022
Manufacturer: EXACTECH, INC.
Product Code: JWH
UDI-DI: 10885862039590
PMA / PMN Number: K932690
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

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, MANUFACTURING, OR PATIENT RELATED ISSUES. THE CAUSE OF THE PAIN CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY IS RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

Additional Manufacturer Narrative · 0

CONCOMITANT MEDICAL PRODUCTS: LOGIC CR FEMORAL CEM, LEFT SZ 1.5 (CAT#: 02-010-03-0215/SERIAL#: (B)(4)); LGC TIBIAL FIT TRAY CEM SZ 1.5F/1.5T (CAT#: 02-012-45-1515/SERIAL#: (B)(4)); LOGIC TIB INSERT IMPL CRC, SZ 1.5, 13MM (CAT#: 02-012-51-1513/SERIAL#: (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Description of Event or Problem · 0

AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT PRESENTED WITH ANTERIOR LEFT KNEE PAIN, SO PATELLA WAS REMOVED, ANOTHER RESECTION MADE AND A LARGER 35 PATELLA WAS CEMENTED. A POPLITEAL RELEASE WAS CONDUCTED AND A 15 CRC POLY REPLACED EXISTING 13 CRC. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO DEVICES DISPOSED BY THE HOSPITAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1908199	THREE PEG PATELLA 32MM	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED	JWH	EXACTECH, INC.	THREE PEG PATELLA 32MM	UNK	10885862039590

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR	Female	Required Intervention