Catalog Number UNK HIP ACETABULAR POLY/METAL |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint (b)(4) d4: the device catalog number is unknown; therefore, udi is unavailable.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.
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Event Description
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It was reported that the self-centering bi-articular domes potentially defective due to apparent inadequate seating of the polyethylene inside the metal dome surgery was delayed 25 minutes due to the reported event.The self-centering 45d.Was changed with a smaller one of 1 mm (from 45 to 44 in diameter), was procedure successfully completed? yes, were fragments generated? no,.
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Manufacturer Narrative
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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, which 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.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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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 which 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: according to the information received, ¿self-centering bi-articular domes potentially defective due to apparent inadequate seating of the polyethylene inside the metal dome.¿ the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the self cent hip 45x28 gry presents nothing indicative of a device nonconformance.No sings of damage nor cosmetic defects that could have contributed to the reported event were observed.Functional evaluation was conducted using a retained sample of a femoral head and stem that matched the size of the implant.The liner and the collar where able to be removed from the shell and assembled the mating implants as intended.Furthermore, the liner was able to snap back into the shell without difficulties.The reported complaint condition was not able to be replicated.A manufacturing record evaluation was performed for the finished device [103545000 / d23090551] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was not confirmed as the observed condition of the self cent hip 45x28 gry would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 12-sep-2023.3) any anomalies or deviations identified in dhr: no nonconformities were identified.4) expiry date: 31-aug-2028.5) ifu reference: (b)(4).Device history review: a manufacturing record evaluation was performed for the finished device [103545000 / d23090551] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.
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Search Alerts/Recalls
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