SMITH & NEPHEW ORTHOPAEDICS AG BIPOLAR PROSTHESIS 42/22; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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Catalog Number 75004335 |
Device Problem
Material Separation (1562)
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Patient Problem
Injury (2348)
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Event Date 10/08/2019 |
Event Type
Injury
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Event Description
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It was reported a revision surgery, performed due to disassociation.Ball head (cocr) and stem (sl-plus) were removed.
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Event Description
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It was reported a revision surgery, performed due to disassociation.Ball head (cocr) and bipolar head were removed.
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Manufacturer Narrative
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It was reported a revision surgery, performed due to disassociation.Ball head (cocr) and bipolar head, used in treatment, were removed and sent back for investigation.He ball head shows only small signs of wear and tear.In contrast to the prosthesis, where some scratches are visible on the polished surface.The shell includes the pe inlay.The retaining pe-ring is really worn down and shows heavy wear.It is assumed that there was a heavy friction between metall ball head and retaining ring.Dislocation of hip implants e.G.Ball heads is a known side effect and is described in our ifu for hip implants 12.23.No other complaint found for the reported batch numbers b0711396 and c0800173.No deviation according to manufacturing specification found in the corresponding batch records.Nevertheless, medical records were not provided therefore a thourough clinical investigation couldn't be performed and the root cause couldn't be determined.If further information get available the complaint will be re-assessed.S+n will monitor this device for further investigations.
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