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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA KR TIBIAL LINER LEFT #8; KR LINER LEFT #8 - H. 12
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LIMACORPORATE S.P.A. PHYSICA KR TIBIAL LINER LEFT #8; KR LINER LEFT #8 - H. 12 Back to Search Results
Model Number 6532.50.812
Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)
Patient Problem Insufficient Information (4580)
Event Date 04/22/2021
Event Type  Injury  
Manufacturer Narrative
By checking the dhr of the lot #14l0124, no pre-existing anomalies were detected on the pieces manufactured with this lot #.This is the first and only complaint received on this lot#.We will submit a final mdr once the investigation will be completed.
 
Event Description
During a right knee surgery performed on (b)(6) 2021, the left component physica kr tib.Liner left #8 (product code 6532.50.812, lot# 14l0124 - ster.1900395) was implanted in the right knee.The incorrect side kr liner was inserted with the contra lateral femur.It was reported that both sides of physica kr liners were available in the operating room.Patient is a male, (b)(6) years old.Event happened in the us.
 
Manufacturer Narrative
By checking the dhr of the lot #14l0124, no pre-existing anomalies were detected on the pieces manufactured with this lot #.This is the first and only complaint received on this lot#.We will submit a final mdr once the investigation will be completed.
 
Event Description
During a right knee surgery performed on april 22nd, 2021, the left component physica kr tibial liner left #8 (product code 6532.50.812, lot# 14l0124 - ster.1900395) was implanted in the right knee.The incorrect side kr liner was inserted with the contra lateral femur.It was reported that both sides of physica kr liners were available in the or.Patient is a male, 64 years old.As an update, we were informed that on july,27th 2021 surgeon opted for a revision surgery where a right physica kr tibial liner #8 - product code 6531.54.812, lot# 2021290, ster.2100076 - was correctly implanted.Event happened in the us.
 
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Brand Name
PHYSICA KR TIBIAL LINER LEFT #8
Type of Device
KR LINER LEFT #8 - H. 12
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via naazionale 52
villanova di san daniele, udine 33038
IT  33038
MDR Report Key11806209
MDR Text Key249981728
Report Number3008021110-2021-00036
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
PMA/PMN Number
K141934
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number6532.50.812
Device Lot Number14L0124
Is the Reporter a Health Professional? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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