Model Number 1322.09.420 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Muscle/Tendon Damage (4532)
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Event Date 02/20/2024 |
Event Type
Injury
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Manufacturer Narrative
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Checking the dhrs of the involved lot #1310134, no pre-existing anomaly was found on the 20 devices manufactured with that lot #.According to our records, at least 17 out of 20 humeral heads with lot #1310134 and ster.1300255 have been implanted and this is the only complaint received on this lot #.Device analysis devices involved were not returned to limacorporate for further analysis.No additional details were available on this event, specifically pre-operative x-rays were asked to the complaint source but weren't 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 manufacturing charts highlighted no anomalies on the components manufactured with the involved lot #1310134, and that the survivorship of the prosthesis is of about 9 years, we can state that the event is not product related.Pms data: according to limacorporate pms data, the revision rate of smr anatomic prosthesis (total and hemi) 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 continues monitoring the market to promptly detect any similar issue.Note: this is a combined initial-final mdr.
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Event Description
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Shoulder revision surgery of a smr anatomic total prosthesis that has taken place on on (b)(6), 2024, due to cuff failure.The following components were removed, and the prosthesis was converted to smr reverse: smr humeral head ø42 mm (product code 1322.09.420, lot #1310134 - ster.1300255).Smr eccentric adaptor taper standard (product code 1330.15.272, lot #1412089 - ster.1400328).Smr finned humeral body (product code 1350.15.110, lot #1412459 - ster.1400332).Liner for metalback glenoid small-r (product code 1377.50.005, lot #1307846 - ster.1300230).Previous surgery was a primary, and it took place on (b)(6) 2015.Patient is a female.Event happened in australia.
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Search Alerts/Recalls
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