FDA Adverse Event Injury Summary report: N

LINER: MPACT FLAT PE HC LINER Ø32/C

MDR report key: 13820177 · Received March 19, 2022

Report

Report Number: 3005180920-2022-00200
Event Type: Injury
Date Received: March 19, 2022
Date of Event: February 25, 2022
Report Date: March 18, 2022
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LPH
UDI-DI: 07630030811845
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 02 MARCH 2022: LOT 2001302: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2020. EXPIRATION DATE: 2025-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY 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. 2001866. BATCH REVIEW PERFORMED ON 02 MARCH 2022: LOT 2001866: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JULY-2020. EXPIRATION DATE: 2025-06-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

Description of Event or Problem · 0

THE PATIENT CAME IN FOR A POST-OP APPOINTMENT REPORTING PAIN. THE SURGEON SUSPECTED THAT A LOOSE CUP WAS THE CAUSE OF PAIN. AT 1 YEAR AND 4 MONTHS AFTER PRIMARY DURING THE REVISION SURGERY, THE SURGEON FOUND THE CUP WAS WELL FIXED AND DECIDED TO ONLY REVISE THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CAUSE OF THE PAIN IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
545103	LINER: MPACT FLAT PE HC LINER Ø32/C	ACETABULAR PE HC LINER	LPH	MEDACTA INTERNATIONAL SA	01.32.3239HCT	2001302	07630030811845

Patients

Seq	Age	Sex	Outcome	Treatment
1		Female	Required Intervention