Model Number 1352.15.005 |
Device Problems
Device Slipped (1584); Device Dislodged or Dislocated (2923)
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Patient Problem
No Code Available (3191)
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Event Date 01/30/2019 |
Event Type
Injury
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Manufacturer Narrative
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A check of the manufacturing charts of all the lots # involved has been made.By checking the manufacturing charts of these lot #s, no anomaly was detected on the products placed on the market, meaning that they had no pre-existing anomaly.No other complaint received on these lot #s.We will proceed with further investigations and submit a final mdr once concluded.
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Event Description
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Revision surgery of shoulder implants performed on (b)(6) 2019, primary surgery performed on (b)(6) 2018.Revision surgery was due to luxation/dislocation, which has caused partial erosion of the proximal humerus.During the revision surgery, only the glenosphere (code #1374.50.400, not marked in us) and the humeral components (smr reverse humeral body short code 1352.15.005 lot# 1401720; smr connector small code 1374.15.310 lot# 1813157; cemented stem code 1306.15.120 lot# 1503890) have been replaced.To improve the stability of the prosthetic joint, the surgeon decided to change the 40 mm liner to a 44 mm one.While removing the primary liner, the humeral components became loose hence the surgeon replaced them.According to the info provided, a rigorous physio not indicated by the surgeon could have led to implant dislocation.Event occurred in (b)(6).
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Manufacturer Narrative
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Check of the dhr: by checking the manufacturing charts of the lots involved, no anomaly was detected on the products placed on the market, meaning that they had no pre-existing anomaly.This is the first and only complaint received with these lot #s.Explants analysis: explants not available to be returned to lima corporate for further analysis (disposed off as per hospital policy).X-rays analysis: x-rays not available for further analysis.Based on the very few info received, we can conclude that this event was most likely related to untimely rehab and poor patient condition.Event not product related.Pms data: according to our pms data, revision rate related to loosening/dislocation of a smr reverse prosthesis is (b)(4).Most of these events reported are related to patient condition or surgical factor.According to the complaints investigated, none of the events reported was product related.No specific corrective action for this case.Lima corporate will continue monitoring the market to promptly detect any future similar issue.
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Event Description
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Revision surgery of a shoulder reverse prosthesis (with custom made glenoid implant) performed on (b)(6) 2019 due to luxation/dislocation of the joint.Partial erosion of the proximal humerus was also reported.Previous surgery was performed on (b)(6) 2018.Components explanted during the revision surgery: smr glenosphere (not marked in usa).Humeral components (smr reverse humeral body short code 1352.15.005 lot# 1401720; smr connector small code 1374.15.310 lot# 1813157; cemented stem code 1306.15.120 lot# 1503890) have been replaced.During the revision surgery, to improve the stability of the prosthetic joint, the surgeon decided to upsize the glenosphere from a 40mm to a 44mm dia.According to the info provided, a rigorous physio - not indicated after a delicate custom made implant and not suggested by the surgeon - was the cause for the implant dislocation.On the 05th of february 2019, complaint source reported us that patient dislocated again due to inflammatory arthritis and poor soft tissue.Event occurred in new zealand.
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Search Alerts/Recalls
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