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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 60MM (TI6AL4V) DIA.13MM
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LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 60MM (TI6AL4V) DIA.13MM Back to Search Results
Model Number 1304.15.130
Device Problem Patient Device Interaction Problem (4001)
Event Date 07/20/2023
Event Type  Injury  
Manufacturer Narrative
Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the overall number.Therefore, all the products with these lot #s have been properly sterilized before being placed on the market.We submit final mdr when investigation is complete.
 
Event Description
Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2023, due to infection.The following components were explanted: smr cementless finned stem, commercial code 1304.15.130 - lot #1500209 - ster.#(b)(4).Smr reverse finned humeral body, commercial code 1352.15.050 - lot #1516394 - ster.#(b)(4).Smr reverse hp liner long, commercial code 1365.09.020- lot #1414479 - ster.#(b)(4), product not sold in the us.Smr connector small r, commercial code 1374.15.305 - lot #1520549- ster.#(b)(4).Smr reverse hp glenosphere 40 mm, commercial code 1374.50.400 - lot #1520517- ster.#(b)(4), product not sold in the us.Smr uncemented glenoid # small-r, commercial code 1375.20.005 - lot #1516951- ster.#(b)(4), product not sold in the us.Bone screw ø6,5 h.25mm, commercial code 8420.15.020 - lot #1519624- ster.#(b)(4).Bone screw ø6,5 h.30mm, commercial code 8420.15.030 - lot #1512625- ster.#(b)(4) a cement spacer was implanted.Previous surgery (primary) date - (b)(6) 2016.Patient - female, sedentary, low bmi.Event happened in australia.
 
Manufacturer Narrative
Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the overall number.Therefore, all the products with these lot #s have been properly sterilized before being placed on the market.The items involved were not available to be returned to limacorporate for further analysis.No additional details were available on this post-operative issue, specifically no pre-operative or post-operative x-rays related to the revision surgery were accessible.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that the check of the sterilization charts highlighted no anomalies on the components manufactured with the involved lot #s, we can state that the event was not product related.Pms data: according to limacorporate pms data, the revision rate of smr reverse implants due to infection is (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.
 
Event Description
Shoulder revision surgery of a smr reverse prosthesis performed on july 20th, 2023, due to infection.The following components were explanted: smr cementless finned stem, commercial code 1304.15.130 - lot #1500209 - ster.#1500050.Smr reverse finned humeral body, commercial code 1352.15.050 - lot #1516394 - ster.#1500392.Smr reverse hp liner long, commercial code 1365.09.020- lot #1414479 - ster.#1500026 - product not sold in the us.Smr connector small r, commercial code 1374.15.305 - lot #1520549- ster.#1600030.Smr reverse hp glenosphere 40 mm, commercial code 1374.50.400 - lot #1520517- ster.#1600006 - product not sold in the us.Smr uncemented glenoid # small-r, commercial code 1375.20.005 - lot #1516951- ster.#1600029 - product not sold in the us.Bone screw ø6,5 h.25mm, commercial code 8420.15.020 - lot #1519624- ster.#1600014.Bone screw ø6,5 h.30mm, commercial code 8420.15.030 - lot #1512625- ster.#1500322 a cement spacer was implanted.Primary surgery took place on (b)(6) 2016.Patient is a female.It was reported she's sedentary and has a low bmi.Event happened in australia.
 
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Brand Name
SMR CEMENTLESS FINNED STEM
Type of Device
FINNED HUMERAL STEMS - 60MM (TI6AL4V) DIA.13MM
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via nazionale 52
villanova di san daniele, udine 33038
IT  33038
MDR Report Key17457190
MDR Text Key320378196
Report Number3008021110-2023-00099
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
PMA/PMN Number
K101263
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 10/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1304.15.130
Device Lot Number1500209
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) Required Intervention;
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