FDA Adverse Event Injury Summary report: N

UNK

MDR report key: 1914956 · Received November 29, 2010

Report

Report Number: 3005751028-2010-00048
Event Type: Injury
Date Received: November 29, 2010
Report Date: November 29, 2010
Manufacturer: ZIMMER TMT
Product Code: HTG
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

NO FURTHER INFO IS PRESENTLY AVAILABLE. BASED ON INFO CITED IN THE ARTICLE, ATTEMPTS ARE BEING MADE TO OBTAIN DETAILS. SHOULD ADDITIONAL INFO BE MADE AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

WHILE REVIEWING AN ARTICLE PUBLISHED IN THE JOURNAL OF ARTHROPLASTY, IT WAS NOTED THAT A PT PRESENTED WITH PERSISTENT ANTERIOR KNEE PAIN. THE SUNRISE RADIOGRAPH ILLUSTRATED AN OBLIQUE CUT MADE ON THE PATELLAR CAUSING A SYMPTOMATIC SUBLUXATION. AT FORMAL ARTHROTOMY, THE PT WAS CUT AGAIN WITH A GUIDE, A CEMENTED ALL-POLYETHYLENE COMPONENT WAS PLACED AND LATERAL RELEASE WAS PERFORMED. HIS CURRENT KNEE SCORES ARE RATED AS EXCELLENT. ARTICLE: "MIDTERM RESULTS OF A POROUS TANTALUM MONOBLOCK TIBIA COMPONENT" BY ANTHONY S. UNGER, MD AND JOHN P. DUGGAN, MD. THE JOURNAL OF ARTHROPLASTY VOL 00 NO 0 2010.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNK	PATELLA	HTG	ZIMMER TMT		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention