FDA Adverse Event Injury Summary report: N

VERSAFITCUP ACETABULAR SHELL CC Ø 56

MDR report key: 8841175 · Received July 30, 2019

Report

Report Number: 3005180920-2019-00654
Event Type: Injury
Date Received: July 30, 2019
Date of Event: July 11, 2019
Report Date: July 30, 2019
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: MEH
UDI-DI: 07630030808173
PMA / PMN Number: K083116
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 22 JULY 2019: LOT 172683: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03.NOV.2017. EXPIRATION DATE: 2022-OCT-23. 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. ADDITIONAL IMPLANT: LINER: VERSAFITCUP DM 01.26.2856MHC VERSAFITCUP DM LINER HC 56/28 (K092265) LOT. 187123. BATCH REVIEW PERFORMED ON 22 JULY 2019: LOT 187123: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13.NOV.2018. EXPIRATION DATE: 2023-OCT-30. 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

SECOND REVISION SURGERY PERFORMED AFTER 3 MONTHS FROM THE FIRST REVISION DUE TO AN INFECTION(THE PATHOGEN IS UNKNOWN). THE CUP AND THE LINER HAVE BEEN REVISED SUCCESSFULLY. THE FIRST REVISION SURGERY HAS BEEN PERFORMED AFTER 4 MONTHS FROM THE PRIMARY ALSO DUE TO AN INFECTION. (PATHOGEN UNKNOWN). THE SURGEON PERFORMED THE WASHOUT AND REVISED ANOTHER COMPANY'S HEAD AND LINER WITH MEDACTA PRODUCTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
635661	VERSAFITCUP ACETABULAR SHELL CC Ø 56	CEMENTLESS ACETABULAR CUP	MEH	MEDACTA INTERNATIONAL SA		172683	07630030808173

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention