Catalog Number 121928148 |
Device Problem
Disassembly (1168)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 09/18/2017 |
Event Type
Injury
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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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The patient was revised to address disassociation of the inlay from the pinnacle cup.It was also reported that the customer was reporting a dysplasia inlay.
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Manufacturer Narrative
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(b)(4).The medical records and x-rays were reviewed by bio engineering.The bio engineering review identified that it was unlikely that a manufacturing defect was present and that no corrective action is required no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : h39303.Device history review: reviewed the attached dhr (h39303).Found no processing variation, scrap or rework required.Sterilization was completed per requirements.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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Complaint description: the patient was revised to address disassociation of the inlay from the pinnacle cup.It was also reported that the customer was reporting a dysplasia inlay.
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Search Alerts/Recalls
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