Model Number 1352.15.005 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
Unspecified Infection (1930)
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Event Date 09/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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By checking the sterilization charts of the involved lot numbers no anomaly was found, meaning that these products had been correctly sterilized before being placed on the market.We will submit a final mdr once the investigation will be concluded.
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Event Description
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First stage shoulder revision surgery due to infection performed on (b)(6) 2018: removal of the implant and insertion of cement spacer.Previous surgery performed on (b)(6) 2018.The involved components are the following: smr reverse humeral body short 1352.15.005 lot# 1808137 ster.1800194; smr reverse hp liner short 1362.09.010 lot# 1508297 ster.1500257; smr reverse hp glenosph.44 mm code 1374.50.440 lot# 1811154 ster.1800237; smr connector small std 1374.15.310 lot# 1809539 ster.1800214; smr uncement.Glenoid # std code 1375.20.010 lot# 1808448 ster.1800219.Among these components only the humeral body and the connector are marketed in the us.Event happened in (b)(6).
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Manufacturer Narrative
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Check of the dhr: by checking the manufacturing and the sterilization charts of the components involved, no anomaly was found on: a total of (b)(4) humeral bodies manufactured with lot# 1808137 ster.1800194.A total of (b)(4) connectors + screws manufactured with lot# 1809539 ster.1800214.By the results of the of the sterilization chart analysis, we can state that all the products previously implanted had been correctly sterilized before being placed on the market.Explants analysis: no explants or pictures available for further analysis.According to the info reported, explants were disposed of as per hospital policy.Xrays analysis: we received only preop xrays referring to the first revision surgery performed on (b)(6) 2019 (smr anatomic hemi prosthesis clearly visible even if no exact date was reported on the xrays).We asked to a medical consultant for a clinical opinion.Following, we reported his conclusion: "i am not aware of any reports of spontaneous loosening even in florid infection that i am aware of so loosening between body and stem.I believe is because the components were never properly engaged in the first place".We did not receive confirmation about the medical opinion but actually our complaint source reported us that during the first stage revision surgery due to infection performed on (b)(6) 2018, it was observed that "the liner off the whole reverse body came loose.Suggesting the taper wasn't engaged properly.Connector screw was loose".We did not receive info related to any previous patient infection or germ responsible for the infection.By the analysis performed and by considering that fixation of the glenoid body to the stem is a function of the morse taper, we can speculate that this case could have been more surgical factor related than product related (connector screw even not tightened enough during the previous surgery).(b)(4).None of the cases we could investigate were classified as product related.No corrective actions planned for this case.Limacorporate will keep monitored the market.
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Event Description
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Smr reverse (first stage) revision surgery due to infection performed on (b)(6) 2018.Clinical history of the patient can be summarized as following: primary surgery performed on (b)(6) 2016.Smr anatomic prosthesis was implanted at this time; first revision surgery due to cuff failure occurred on (b)(6) 2018.Anatomic smr previously implanted was converted to smr reverse prosthesis (event not reported to limacorporate); second revision due to infection: first stage revision was performed on (b)(6) 2018 (object of this current report).According to the info reported, during this stage all the components previously implanted were removed and a cement spacer was inserted.Moreover, when the surgeon removed the humeral body, the device was loosened and the screw had not tightened enough; second stage revision was then performed on (b)(6) (limacorporate complaint # (b)(4)/18 3008021110-2018-00118).Please refer to the final incident report submitted for complaint 395/18 for further details on this event).During first stage revision performed on (b)(6) 2018, the following components have been explanted: humeral body code 1352.15.005 lot# 1808137 ster.1800194, connector+screw code 1374.15.310 lot# 1809539 ster.1800214, glenosphere (not marked in usa).Liner (not marked in usa).Glenoid (not marked in usa).Event occurred in australia.
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