MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA KR TIB. LINER LEFT #5; KR LINER LEFT #5 - H. 16 (HRY JWH)

Model Number 6532.50.516

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

Patient Problem Unspecified Infection (1930)

Event Date 09/19/2018

Event Type  Injury  

Manufacturer Narrative

We checked the sterilization charts of the following components, implanted during previous surgery: physica kr tib.Liner left #5 code 6532.50.516 lot# 14l0624, ster.1500224; physica kr femur comp.Left #4 code 6511.09.540 lot# 17as01j, ster.1700063; physica fixed tibial plate #5 code 6522.15.050 lot# 1800551, ster.1800062; physica patella prosth.D.29mm code 6595.50.029 lot# 17at1wt, ster.1800001.No anomaly was found, thus all these components had been correctly sterilized before being placed on the market.We will submit a final mdr once the investigation will be concluded.

Event Description

Revision surgery due to infection performed on (b)(6) 2018.During this surgery only the poly liner (code 6532.50.516, lot# 14l0624) was replaced.Previous surgery was performed on (b)(6) 2018.Event happened in the us.

• Brand Name: PHYSICA KR TIB. LINER LEFT #5
• Type of Device: KR LINER LEFT #5 - H. 16 (HRY JWH)
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8018234
• MDR Text Key: 125431965
• Report Number: 3008021110-2018-00070
• 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: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 6532.50.516
• Device Lot Number: 14L0624
• 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