FDA Adverse Event Injury Summary report: N

LINER: MPACT FLAT PE HC LINER Ø36/E

MDR report key: 14165413 · Received April 21, 2022

Report

Report Number: 3005180920-2022-00276
Event Type: Injury
Date Received: April 21, 2022
Date of Event: March 22, 2022
Report Date: April 21, 2022
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 · 0

BATCH REVIEW PERFORMED ON 31 MARCH 2022: LOT 157808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-FEB-2016. EXPIRATION DATE: 2021-02-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 01-01-2018. OTHER DEVICES INVOLVED: STEM: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4 (K093944) LOT. 160737: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2016. EXPIRATION DATE: 2021-05-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 01-01-2018 (RESTERILIZED DEVICES CONSIDERED). BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 155424: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-DEC-2015. EXPIRATION DATE: 2020-12-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2018.

Description of Event or Problem · 0

REVISION SURGERY 5 YEAR AND 6 MONTHS AFTER PRIMARY. THE REASON OF PAIN IS UNKNOWN. STEM, HEAD AND LINER REVISED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1957465	LINER: MPACT FLAT PE HC LINER Ø36/E	HIP ACETABULAR LINER PE	LPH	MEDACTA INTERNATIONAL SA	01.32.3644HCT	157808	07630030812118

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Required Intervention