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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 - 80MM (TI6AL4V) DIA.15MM
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LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.15MM Back to Search Results
Model Number 1304.15.150
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Staphylococcus Aureus (2058)
Event Date 09/23/2020
Event Type  Injury  
Manufacturer Narrative
By checking the sterilization charts of the involved products, no pre-existing anomalies were found thus we can state that all the components had been regularly sterilized before being placed on the market.We will submit a final mdr once the investigation will be completed.
 
Event Description
Revision surgery due to infection performed on (b)(6) 2020.It was reported that the patient has had chronic pain since the primary surgery.The following components were explanted: smr cementless finned stem (product code: (b)(4), lot# 1714680 - ster.1800003); smr humeral extension + 9 mm (product code: (b)(4), lot# 1800447 - ster.1800062); smr reverse humeral body (product code: (b)(4), lot# 1713303 - ster.1700383); smr reverse hp liner short (product code: (b)(4), lot# 1804692 - ster.1800135); smr connector small r (product code: (b)(4), lot# 1714813 - ster.1800023); smr reverse hp glenosph.40 mm (product code: (b)(4), lot# 1800696 - ster.1800021); smr uncement.Glenoid #small-r (product code: (b)(4), lot# 1802174 - ster.1800091); bone screw ø6,5 h.20mm (product code: (b)(4), lot# 1802644 - ster.1800086) bone screw ø6,5 h.20mm (product code: (b)(4), lot# 1704083 - ster.1700151) an antibiotic spacer was implanted and a bone graft was placed in the glenoid.It was reported that from the biopsies taken from the patient, two different staphylococcus grew on two different specimens.Previous surgery on (b)(6) 2018.Patient is a female, born on (b)(6).Event occurred in (b)(6).
 
Manufacturer Narrative
By checking the sterilization charts of the involved products, no pre-existing anomalies were found thus we can state that all the components had been regularly sterilized before being placed on the market.Explants analysis: explanted component not available for further analysis.Complaint source reported that patient was biopsied and grew 2 different staphs on 2 different specimens.We received some pictures of the explants.X-rays analysis: we received some pre-op revision x-rays dated (b)(6) 2020.We asked for a clinical opinion about the case to our medical consultant.Following his statement: "we have no information on comorbidities so assume there are none.The 2 different staph species confound things and a definite diagnosis of infection cannot be made.We do not have any other data available that would assist us further.This patient has had pain from the outset and this feature has been recognised on our registry as "pain from no obvious cause" which we now suspect in most cases is "occult infection".I do not see any obvious features on the x rays that would be consistent with infection.The metal back baseplate is significantly "too high" and there is impingement as a consequence.There is no hard data that correlates impingement with infection but again we are suspicious of that possibility.The surgeon will have information available that would allow better judgement on the appropriateness or otherwise of the decision to bone graft, but if overt infection was present conventional wisdom would be not to do that.In summary a likely low grade infection has occurred from the time of the index procedure, ie this is an early surgery related (and not blood borne infection).The base plate is too high and while this is surgeon error there is no data that supports this being associated with infection" stating that: no pre-existing anomalies were found by checking the sterilization charts of the involved products; the medical consultant highlighted that ".The base plate is too high and while this is surgeon error there is no data that supports this being associated with infection" no specific root cause can be assigned to this case.Based on the investigation performed we cannot classify this event as product related.Pms data: revision rate related to infection of smr reverse prosthesis is 0.06%.No specific corrective actions for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.
 
Event Description
Revision surgery of a smr reverse prosthesis performed on (b)(6) 2020 due to infection.It was reported that the patient has had chronic pain since the primary surgery.The following components were explanted: smr cementless finned stem (product code 1304.15.150, lot# 1714680 - ster.1800003); smr humeral extension + 9 mm (product code 1352.15.001, lot# 1800447 - ster.1800062); smr reverse humeral body (product code 1352.20.010, lot# 1713303 - ster.1700383) product not sold in us; smr reverse hp liner short (product code 1365.09.010, lot# 1804692 - ster.1800135) - product not sold in us; smr connector small r (product code 1374.15.305, lot# 1714813 - ster.1800023); smr reverse hp glenosph.40 mm (product code 1374.50.400, lot# 1800696 - ster.1800021) - product not sold in us; smr uncement.Glenoid #small-r (product code 1375.20.005, lot# 1802174 - ster.1800091) - product not sold in us; bone screw ø6,5 h.20mm (product code 8420.15.010, lot# 1802644 - ster.1800086); bone screw ø6,5 h.20mm (product code 8420.15.010, lot# 1704083 - ster.1700151).An antibiotic spacer was implanted and a bone graft was placed in the glenoid.It was reported that from the biopsies taken from the patient, two different staphylococcus grew on two different specimens.Previous surgery on (b)(6) 2018.Patient is a female, born on (b)(6) 1939.Affected by type 2 diabetes, asthma and sleep apnoea.Event occurred in australia.
 
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Brand Name
SMR CEMENTLESS FINNED STEM
Type of Device
FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.15MM
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via nazionale 52
villanova di san daniele, udine 33038
IT  33038
MDR Report Key10619209
MDR Text Key214732967
Report Number3008021110-2020-00080
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
Type of Report Initial,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number1304.15.150
Device Lot Number1714680
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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