DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX NEUT 36IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
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Catalog Number 122136054 |
Device Problem
Defective Device (2588)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Business unit: (b)(4).Date j&j became aware: 23/04/2018.Date of event: unknown.Name of reporter: (b)(6) clinical specialist depuy.Hospital name: (b)(6) hospital.Product name: marathon 36x54mm liner.Product code:1221-36-054.Lot/batch/exp: unknown.Was the product being used in a clinical trial? no.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? no.Event outcome/how was it managed? replacement implant used.Was there any consequence to the patient due to the event? no.Was the surgery prolonged due to the event? if yes, confirm how many minutes delay.No.Has the reporter facility indicated there may be legal action? no.Is the product available for return? yes.Please give a detailed explanation of the event: total hip replacement, surgeon insisted that marathon liner that was being used had a larger, internal diameter than stated (36mm internal ).He showed that a 36mm head seemed to not fit properly, within the 36mm liner.A replacement liner was used with no issue.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: examination of the returned device finds nothing outward to suggest product error.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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