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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM
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LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM Back to Search Results
Model Number 1304.15.180
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Failure of Implant (1924); Unspecified Infection (1930)
Event Date 04/11/2019
Event Type  Injury  
Manufacturer Narrative
By checking the manufacturing charts of the components marketed in usa (stem lot# 1509599, connector lot# 1510159, screw lot# 1508895), no pre-existing anomaly was found on the products placed on the market with these lot #s.We will submit a final mdr once the investigation will be concluded.
 
Event Description
Shoulder revision surgery performed on (b)(6) 2019.Reported cause for this revision was the loosening of the metal back glenoid with code 1375.20.005 lot# 1508742 (this product code is not marketed in the us).During this surgery all the components have been removed (stem 1304.15.180, lot# 1509599; humeral body 1352.20.010 lot# 1519789; reverse liner 1365.09.010, lot# 1510333; connector 1374.15.305, lot# 1510159; glenosphere 1374.50.400, lot# 1601035; metal back glenoid 1375.20.005, lot# 1508742, bone screw 8420.15.030, lot# 1508895).Among the abovementioned components, only the stem, the connector and the screw are marketed in the us).Components implanted on (b)(6) 2016.A possible malpositioning of the metal back has also been reported to us by the complaint source.Moreover, according to the info reported, this patient had previously developed an infection (details unknown) and experienced 2 falls.Event happened in (b)(6).
 
Manufacturer Narrative
Dhrs check: by checking the manufacturing chart of the involved lot# (1508742) no pre-existing anomaly was found on the (b)(4) pieces placed on the market with this lot#.We also checked the dhrs of the components marketed in usa (stem lot# 1509599, connector lot# 1510159, screw lot# 1508895), no pre-existing anomaly was found on the products placed on the market with these lot#s.No other complaints received on these lot#s.Explants and xrays analysis: we did not receive the explanted components, only some explants photos have been provided.Pictures were forwarded to our medical consultant for a clinical evaluation, together with 2 x-ray images (unknown dates).Following, the medical expert's opinion received: "we have 2 x-rays, possibly the 2nd x-ray the later of the 2.The second x-ray shows a healed displaced greater tuberosity fracture.The is a lytic reaction medially around the body and very proximal stem.Elsewhere the stem is securely fixed.The glenoid baseplate and glenosphere as stated is completely loose and migrated superiorly.I presume the "inspection" was surgical exposure? the second (3rd procedure) demonstrated evidence of infection.I do not discriminate between superficial and deep infection.Pus anywhere around a shoulder arthroplasty is an infected a pji (periprosthetic joint infection).Lytic reaction around the humerus (as seen here) is consistent with pji.I cannot say what the consequence of the falls was but i would agree the fracture of the greater tuberosity was likely caused by the fall(s)? significant impingement as you describe is the consequence of surgical error placing the baseplate too high on the glenoid." conclusion: we cannot go back with certainty to the root cause of the loosening of the metal back glenoid.According to the info provided, more than one factor could have contributed to this event (as confirmed also by our medical consultant): - 2 falls experienced by the patient over time; - possible original malpositioning of the metal back glenoid during surgery on (b)(6) 2016; - infection (specimens test result not received by lima corporate).Based our analysis, this event cannot be classified as product-related.No specific action for this case, lima corporate will continue monitoring the market to promptly detect any future similar issue.
 
Event Description
Shoulder revision surgery performed on (b)(6) 2019.Reported cause for this revision was the loosening of the metal back glenoid with code 1375.20.005 lot# 1508742.During this surgery all the components have been removed (stem 1304.15.180, lot# 1509599; humeral body 1352.20.010 lot# 1519789; reverse liner 1365.09.010, lot# 1510333; connector 1374.15.305, lot# 1510159; glenosphere 1374.50.400, lot# 1601035; metal back glenoid 1375.20.005, lot# 1508742, bone screw 8420.15.030, lot# 1508895).Components had been implanted on (b)(6) 2016.A possible initial malpositioning of the metal back has also been reported to us by the complaint source.Moreover, according to the info reported, this patient had previously developed an infection and experienced 2 falls.Specifically, we can sum up the events as follows: 1.Primary surgery on (b)(6) 2016 2.Due to patient's fall, the surgeon decided to inspect the joint on (b)(6) 2019, without removing nor implanting any component; 3.After the joint inspection, the patient complained of severe pain in his shoulder and developed an area of redness over the anterior portion of his previous tsf wound.Follow up x-rays showed progressive an high grade scapula notching with the inferior screw being involved in the notching.Subsequently there was evidence that the baseplate had failed and tilted superiorly; 4.Therefore, the surgeon planned another surgery to explore the wound.There seemed to be a superficial infection but did not appear to go deeper.The decision was made not to proceed deeper so as not to allow the superficial infection to contaminate the deeper layers.Specimens were collected and sent to microbiologist for analysis.The plan forward was to continue antibiotics treatment.During this surgery no component was removed nor implanted; 5.According to the info received, the patient experienced then a second fall; 6.A different surgeon revised the patient on (b)(6) 2019 and removed all components.The entire glenoid construct was removed by hand as the metal back glenoid had loosened.The humeral components were well fixed and required significant effort to remove.Patient was irrigated and closed-up.During this surgery no components have been implanted (removal only).Event happened in australia.Note: the suspected code (metal back glenoid 1375.20.005) is not marketed in the us.The event was reported to fda because some of the explanted components (stem 1304.15.180, connector 1374.15.305 and bone screw 8420.15.030) are marketed in the usa.
 
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Brand Name
SMR CEMENTLESS FINNED STEM
Type of Device
SMR CEMENTLESS FINNED STEM
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via nazionale 52
villanova di san daniele, 33038
IT  33038
MDR Report Key8527246
MDR Text Key142406954
Report Number3008021110-2019-00050
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number1304.15.180
Device Lot Number1509599
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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