FDA Adverse Event Injury Summary report: N

LINER: MPACT DOUBLE MOBILITY HC LINER 28/DMD

MDR report key: 16467864 · Received March 2, 2023

Report

Report Number: 3005180920-2023-00130
Event Type: Injury
Date Received: March 2, 2023
Date of Event: September 30, 2022
Report Date: March 2, 2023
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: MEH
UDI-DI: 07630030807244
PMA / PMN Number: K092265
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON (B)(6) 2023 LOT 2103095: 120 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-04-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 113 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON (B)(6) 2023: CUP: MPACT 01.32.148MB DOUBLE MOBILITY ACETABULAR SHELL Ø48 (K143453) LOT. 2102139 LOT 2102139: 28 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-06-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM.TO DATE, 27 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

Description of Event or Problem · 0

AFTER MEDACTA PRIMARY SURGERY PERFORMED ON (B)(6) 2022 (PREVIOUSLY THE PATIENT HAD COMPETITOR DEVICES), ON (B)(6) 2022 THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT DISLOCATION (DM LINER FROM THE DM CUP) AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, HEAD, AND PROXIMAL BODY OF THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
515750	LINER: MPACT DOUBLE MOBILITY HC LINER 28/DMD	HIP DOUBLE MOBILITY LINER	MEH	MEDACTA INTERNATIONAL SA	01.26.2848MHC	2103095	07630030807244

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Required Intervention