FDA Adverse Event Injury Summary report: N

LINER: MPACT FLAT PE HC LINER 32/E

MDR report key: 11587644 · Received March 30, 2021

Report

Report Number: 3005180920-2021-00253
Event Type: Injury
Date Received: March 30, 2021
Date of Event: March 4, 2021
Report Date: March 30, 2021
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LPH
UDI-DI: 07630030811913
PMA / PMN Number: K103721
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 16.MAR.2021: LOT 186966: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2018. EXPIRATION DATE: 2023-10-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115) LOT. 1901937. BATCH REVIEW PERFORMED ON 16.MAR.2021: LOT 1901937: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2019. EXPIRATION DATE: 2024-06-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

Description of Event or Problem · 1

THE PATIENT CAME IN 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD AND LINER AND ADDED A SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON NOTICED THAT THE PATIENT'S LEG WAS A BIT SHORT IN LENGTH COMPARED TO HIS OTHER LEG, SO HE DECIDED TO UPSIZE THE HEAD DURING THE REVISION TO GIVE THE PATIENT MORE LENGTH IN HIS LEG.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
485713	LINER: MPACT FLAT PE HC LINER 32/E	ACETABULAR PE HC LINER	LPH	MEDACTA INTERNATIONAL SA	01.32.3244HCT	186966	07630030811913

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention