SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Model Number 71337652 |
Device Problems
Device Markings/Labelling Problem (2911); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during hip replacement, it was observed that an r3 acetabular liner 32mm inner diameter x outer diameter 52mm had number 50 inscribed on the external box of the implant, instead of number 52.The surgery was resumed, without any delay, the same device.When reviewing the implants used, it was noticed that the implant with the reference 32/52 sticker is missing, and it was later notified by x-ray that there was an anomaly with the insert.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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Section b5 and d3 were updated according to the new information received.Section h6 was corrected according to the new information received.Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the product was not faulty and the cause was associated with an omission on the part of the surgical instrumentation operator that confused the measurements of the implant.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Event Description
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It was reported that, during hip replacement, it was thought that an r3 acetabular liner 32mm inner diameter x outer diameter 52mm had number 50 inscribed on the external box of the implant, instead of number 52.The surgery was resumed, without any delay, the same device.When reviewing the implants used, it was noticed that the cause was associated with an omission on the part of the surgical instrumentation operator that confused the measurements of the implant.Patient's health is stable and was not injured as consequence of this problem.
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Search Alerts/Recalls
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