FDA Adverse Event Injury Summary report: N

MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 6

MDR report key: 7086820 · Received December 6, 2017

Report

Report Number: 3005180920-2017-00726
Event Type: Injury
Date Received: December 6, 2017
Date of Event: November 7, 2017
Report Date: December 6, 2017
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630030885556
PMA / PMN Number: K151531
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 24 NOVEMBER 2017: TEN MONTHS AFTER IMPLANTATION, THE PATIENT WAS COMPLAINING OF INSTABILITY. DURING REVISION SURGERY THE STEM WAS WELL FIXED AND THE SURGEON DECIDED TO CHANGE THE FEMORAL HEAD. ACCORDING TO THE REPORT THE STEM SLIGHTLY SUBSIDED. A SINGLE RADIOGRAPHIC PROJECTION WITHOUT INDICATION OF TIME WAS PROVIDED AND EVALUATION OF POTENTIAL IMPLANT MIGRATION IS NOT POSSIBLE. ON THE BASIS OF INFORMATION PROVIDED, THE REASON OF THIS EVENT CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON 04 DECEMBER 2017: LOT 162764: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JUNE 2016. EXPIRATION DATE: 2021-06-02 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

Description of Event or Problem · 1

THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON DETERMINED THAT THE STEM HAD SLIGHTLY SUBSIDED. THE SURGEON SWAPPED THE HEAD AND IMPLANTED AN OPTION SLEEVE WITH ANOTHER HEAD. THE STEM WAS NOT REVISED AS IT IS NOW STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
867592	MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 6	HIP CEMENTLESS STEM	LZO	MEDACTA INTERNATIONAL SA		162764	07630030885556

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention