MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA KR TIB. LINER RIGHT #7; PHYSICA KR TIB. LINER RIGHT #7 (HRY JWH)

Model Number 6531.50.710

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Unspecified Infection (1930); Sepsis (2067)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

By the check of the sterilization charts, no anomaly was detected on the 34 liners placed on the market with the same lot (15at2b3 ster 1600133): these components had been regularly sterilized before reaching the market.We will submit a final mdr as soon as the investigation will be concluded.

Event Description

Revision surgery due to infection performed on (b)(6) 2020.Previus surgery took place on (b)(6) 2019.It was reported that the septic arthiris was caused by leg cellulosis.According to the info received, only the poly liner (65315.07.100, lot 15at2b3 ster.1600133) was replaced.The surgeon commented that the sinovial fluid was positive with (b)(6).Event happened in usa.

• Brand Name: PHYSICA KR TIB. LINER RIGHT #7
• Type of Device: PHYSICA KR TIB. LINER RIGHT #7 (HRY JWH)
• Manufacturer (Section D): LIMACORPORATE S.P.A.; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9681195
• MDR Text Key: 178179358
• Report Number: 3008021110-2020-00005
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K141934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 6531.50.710
• Device Lot Number: 15AT2B3
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention