Model Number 1217-01-056 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/18/2022 |
Event Type
malfunction
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Event Description
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It was reported that intraoperatively, after impacting the cup and screwing in the hole eliminator, the surgeon wanted to correct the position of the cup.In order to insert the cup impactor, the apex hole eliminator should have been removed, which unfortunately was not possible.The surgeon decided to insert the inlay and reposition the hip.As a result of the trial reposition the hip dislocated and the cup was completely changed.No patient harm reported.There was a 30 minute surgical delay.
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Manufacturer Narrative
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(b)(4) depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch 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.H10 additional narrative: added: d9 and d10.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was received for examination.Visual inspection of the device found it is off axis threaded/mispositioned to the mating device.The reported condition was confirmed.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: product description: pinnacle 100 acet cup 56mm.Product code: 121701056, lot number: 3752013.Please provide: 1) quantity manufactured: (b)(4).2) date of manufacture: 05-apr-2022.3) any anomalies or deviations identified in dhr: there were no non-conformances associated with this lot.4) expiry date: 31-mar-2032.5) ifu reference: ifu-0902-00-701.Device history review: a manufacturing record evaluation was performed for the finished device 3752013 121701056, and no non-conformances or manufacturing irregularities related to the malfunction were identified.
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Search Alerts/Recalls
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