Model Number 38AM4035 |
Device Problems
Fitting Problem (2183); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problems
Metal Related Pathology (4530); Insufficient Information (4580)
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Event Type
Injury
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Event Description
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Allegedly, patient was revised due to unknown reasons.
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Manufacturer Narrative
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The alleged complaint could not be confirmed.The provided incident report states that this patient was revised resulting from "surgeon preference regarding patient condition." microport post market quality contacted the reporting sales representative regarding the possible causes concerning the described patient condition, but the sales representative did not provide any additional information related to this event.Review of the device history record (dhr) for this lot indicates that these products met all established acceptance criteria throughout the manufacturing process.Review of historical complaint data reveals no lot trends for any complaint modes.There is not enough information to investigate this complaint.No information regarding a product failure or any specific complications were made available.This investigation will be reopened if additional information is received.
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Manufacturer Narrative
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Updated: description, events' codes and investigation codes were changed.
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Event Description
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Allegedly, patient was revised due to unknown reasons.Additional information received on 03/21/2023: allegedly, on or about (b)(6) 2021 plaintiff reported for a revision/replacement if the femoral head and neck.Dr recommended the revision surgery after plaintiff presented with pain and weakness, adverse local tissue reaction and elevated cobalt levels.Neck (pha01242) and head (pha04426) were implanted during the revision surgery.Products not revised: product id: lot number: qty: 20070031 1830209 1.Dspcgf56 1822203 1.Pha00248 01112839031803042 1.Dlxplf40 15418741813633 1.18080304 177194 1.18080303 1802295 1.
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Search Alerts/Recalls
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