Catalog Number 122136152 |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problems
Foreign Body Reaction (1868); Joint Laxity (4526)
|
Event Date 02/17/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Event Description
|
It was reported that the revision performed due to severe metallosis likely due to mal-positioning of cup and mal-placement of liner with lid placed posteriorly.Liner was disassociated and cup was fractured with a 1 cm divot worn into the side of the acetabular shell most likely from the neck of the stem.There was loosening of liner from cup at the non-cemented loosening interface.Doi: (b)(6) 2018 dor: (b)(6) 2024 affected side: left hip.
|
|
Manufacturer Narrative
|
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: h6 health effect- clinical code if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|