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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD Ø44 MM; HUMERAL HEADS (COCRMO) DIA.44MM

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LIMACORPORATE S.P.A. SMR HUMERAL HEAD Ø44 MM; HUMERAL HEADS (COCRMO) DIA.44MM Back to Search Results
Model Number 1322.09.440
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Muscle/Tendon Damage (4532); Implant Pain (4561)
Event Date 09/07/2023
Event Type  Injury  
Event Description
Shoulder revision surgery of a smr anatomic total prosthesis performed on (b)(6) 2023, due to cuff failure and pain.Surgeon noted that possibly the humerus was too high.The following components got explanted and the prosthesis was converted to reverse: smr humeral head ø44 mm (product code: 1322.09.440, lot#: 1805916 - ster.1800148).Smr eccentric adaptor taper standard (product code: 1330.15.274, lot#:1809773 - ster.1800233).Smr trauma humeral body # medium (product code: 1350.15.010, lot#:1814079 - ster.1800317).Cemented glenoid 3 pegs small (product code: 1379.51.020, lot#: 17at0x9 - ster.1800086).Primary surgery took place on (b)(6) 2018.Patient is a female, 60 years old.No clinical info is available.It was reported that patient had 3-4 previous surgeries after the proximal humeral fracture, but no information is available on them.Event happened in new zealand.
 
Manufacturer Narrative
Checking the manufacturing charts of the involved lot#: 1805916, no pre-existing anomalies were found on the 68 components manufactured with that lot#.This is the first and only complaint received on the lot#.We submit a final mdr as soon as the investigation is complete.
 
Manufacturer Narrative
Checking the manufacturing charts of the involved lot #1805916, no pre-existing anomaly was found on the 68 components manufactured with that lot #.According to our records, at least 56 out of 68 humeral heads with lot #1805916 and ster.1800148 have been implanted and this is the only complaint received on this lot #.Device analysis the items involved were not available to return to limacorporate for further analysis.X-rays analysis limacorporate received one x-ray referring to pre-operative revision surgery.The x-ray received - exact date unknown - has been evaluated by a medical consultant.Following, the medical consultant comments: "the radiograph shows a big bone resorption under the metaphyseal part of the prosthesis, which looks overstuffed (hard to tell with the amount of missing bone) and high riding (ahd is reduced indicating the rotator cuff failure).This is a fateful course of events after multiple operation post trauma.A surgeon issue is possible, but rather less important than the natural course.There is no implant-related problem here".Considering that: check of manufacturing charts highlighted no anomalies on components manufactured with lot #1805916; according to the surgeon responsible for the revision surgery, possibly the humerus was too high; according to the medical expert "the radiograph shows a big bone resorption under the metaphyseal part of the prosthesis, which looks overstuffed (hard to tell with the amount of missing bone) and high riding.This is a fateful course of events after multiple operation post trauma"; we can state that the event was not product related.Pms data according to limacorporate pms data, revision rate of humeral heads - belonging to the family codes 1322.09.Xxx - due to cuff failure 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 anatomic total prosthesis performed on (b)(6) 2023, due to cuff failure and pain.Surgeon noted that possibly the humerus was too high.The following components got explanted and the prosthesis was converted to reverse: smr humeral head ø44 mm (product code 1322.09.440, lot #1805916 - ster.1800148).Smr eccentric adaptor taper standard (product code 1330.15.274, lot #1809773 - ster.1800233).Smr trauma humeral body # medium (product code 1350.15.010, lot #1814079 - ster.1800317).Cemented glenoid 3 pegs small (product code 1379.51.020, lot #17at0x9 - ster.1800086).Primary surgery took place on (b)(6) 2018.Patient is a female, 60 years old.No clinical info is available.It was reported that patient had 3-4 previous surgeries after the proximal humeral fracture, but no information is available on them.Event happened in new zealand.
 
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Brand Name
SMR HUMERAL HEAD Ø44 MM
Type of Device
HUMERAL HEADS (COCRMO) DIA.44MM
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via nazionale 52
villanova di san daniele, udine 33038
IT  33038
MDR Report Key17779140
MDR Text Key323789307
Report Number3008021110-2023-00107
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K100858
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 12/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1322.09.440
Device Lot Number1805916
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/20/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/07/2023
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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