FDA Adverse Event Injury Summary report: N

LINER: MPACT FLAT PE HC LINER Ø36/E

MDR report key: 8188876 · Received December 21, 2018

Report

Report Number: 3005180920-2018-01034
Event Type: Injury
Date Received: December 21, 2018
Date of Event: November 28, 2018
Report Date: December 21, 2018
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LPH
UDI-DI: 07630030812118
PMA / PMN Number: K103721
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 21 DECEMBER 2018. LOT 184753: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 SEPTEMBER 2018. EXPIRATION DATE: 2023-08-28. 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 COMPONENTS REVISED: STEM: AMISTEM C 01.18.151 CEMENTED STD STEM #1 (K103189), LOT 180770: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JUNE 2018. EXPIRATION DATE: 2023-05-17. 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. BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0 (K080885), LOT 174673: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 NOVEMBER 2017. EXPIRATION DATE: 2022-11-05. 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 DUE TO SIGNS OF INFECTION ABOUT 3 MONTHS AFTER PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1028447	LINER: MPACT FLAT PE HC LINER Ø36/E	HIP PE HC LINER	LPH	MEDACTA INTERNATIONAL SA		184753	07630030812118

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention