Shoulder revision surgery of a hemi prosthesis performed on (b)(6) 2021, due to patient experiencing pain.The following components were explanted: smr humeral head ø46 mm (product code 1322.09.460, lot# 1114226 - ster.1200021).Smr trauma humeral body # medium (product code 1350.15.010, lot# 1214162 - ster.1300077).The implant was converted to reverse.Previous surgery took place on (b)(6) 2013.Patient is a male.Event happened in (b)(6).
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By checking the manufacturing charts of lot #1114226 - ster.1200021, no pre-existing anomaly was found on a total of (b)(4) items manufactured with the same lot#.According to our records, at least 66 out of (b)(4) humeral heads with lot# 1114226 - ster.1200021 have been implanted and this is the only complaint received on this lot #.By checking the manufacturing charts of lot #1214162 - ster.1300077, no pre-existing anomaly was found on a total of (b)(4) items manufactured with the same lot#.According to our records, all (b)(4) humeral bodies with lot# 1214162 - ster.1300077 have been implanted and this is the only complaint received on this lot #.No additional details were available on this post-operative issue, specifically the following information was requested to the complaint source, but it was not available: pre-operative x-rays related to the revision surgery; explanted items.Based on the very few information received, we are not able to further investigate the root cause of the event.However, stating that: the check of the manufacturing charts highlighted no anomalies on the total number of components manufactured with lot #1114226 and lot #1214162; according to the further information reported, patient had a fall which caused trauma and pain; we can conclude that the event was patient related.Pms data according to limacorporate pms data, revision rate of smr anatomic hemi prosthesis due to pain 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.
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Shoulder revision surgery of a smr anatomic hemi prosthesis performed on (b)(6) 2021, due to patient experiencing pain.It was further reported by the complaint source that patient had a fall which caused trauma and therefore pain.The following components were explanted: smr humeral head ø46 mm (product code 1322.09.460, lot# 1114226 - ster.1200021).Smr trauma humeral body # medium (product code 1350.15.010, lot# 1214162 - ster.1300077).The implant was converted to a smr reverse prosthesis.Previous surgery took place on (b)(6) 2013.Patient is a male, 71 years old.Event happened in australia.
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