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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR REVERSE HUMERAL BODY
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LIMACORPORATE S.P.A SMR REVERSE HUMERAL BODY Back to Search Results
Model Number 1352.15.010
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Joint Laxity (4526)
Event Date 10/16/2023
Event Type  Injury  
Manufacturer Narrative
Checking the manufacturing charts of the involved lot #s, no pre-existing anomaly was found on the devices.This is the first and only complaint involving these lot #s.Therefore, we can conclude that the products have been correctly manufactured before being placed on the market.Will file final mdr report when investigation is completed.
 
Event Description
Shoulder revision surgery was performed on (b)(6) 2023: where the humeral stem and humeral body were replaced due to loosening (cause unknown), cultures were taken (pending confirmation of whether these were negative for infection).Previous surgery - (b)(6) 2023.Patient - female.Date of birth - (b)(6) 2023.Event happened in usa.Patient history: failed third-party custom glenoid implant + bone erosion and deformity.Current cultures came back negative.Components explanted: smr cementless finned stem, commercial code 1304.15.150 - lot #2212364 - ster.#2200250.Smr reverse humeral body, commercial code 1352.15.010 - lot #2300313 - ster.#2300050.
 
Event Description
Shoulder revision surgery was performed on (b)(6) 2023: where the humeral stem and humeral body were replaced due to loosening (cause unknown), cultures were taken (pending confirmation of whether these were negative for infection).Previous surgery: on (b)(6) 2023, patient: female, date of birth: on (b)(6) 1963, event happened in: usa.Patient history: failed third-party custom glenoid implant + bone erosion and deformity.Current cultures came back negative.Components explanted: smr cementless finned stem, commercial code: 1304.15.150, lot#: 2212364, ster.#: 2200250.Smr reverse humeral body, commercial code: 1352.15.010, lot#: 2300313, ster.#: 2300050.
 
Manufacturer Narrative
Checking the manufacturing charts of the involved lot#s, no pre-existing anomaly was found on the devices.This is the first and only complaint involving these lot#s.Therefore, we can conclude that the products have been correctly manufactured before being placed on the market.The explanted components involved were not available to be returned to lima corporate for further analysis.X-rays were requested but not available.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 dhr highlighted no anomalies on the components manufactured with the involved lot#s, we can suppose that the event was not product related.Pms data: (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Lima corporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.
 
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Brand Name
SMR REVERSE HUMERAL BODY
Type of Device
SMR REVERSE HUMERAL BODY
Manufacturer (Section D)
LIMACORPORATE S.P.A
via nazionale, 52
villanova di san daniele, udine 33038
IT  33038
Manufacturer Contact
via nazionale, 52
villanova di san daniele, udine 33038
MDR Report Key18146466
MDR Text Key328225224
Report Number3008021110-2023-00118
Device Sequence Number1
Product Code PHX
Combination Product (y/n)N
PMA/PMN Number
K110598
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 03/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1352.15.010
Device Lot Number2300313
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;
Patient Age60 YR
Patient SexFemale
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