Model Number 2975-28-105 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).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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Reclaim hip revision (b)(6) 2020.During reaming of the proximal body the loose parts of the coloured rings were noticed.They used extra pulse lavage to decrease the risk of parts in the patient.
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Manufacturer Narrative
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Product complaint # = > (b)(4) investigation summary = > examination of the returned instrument confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
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Manufacturer Narrative
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Product complaint # (b)(4).All medical device reports associated with the same/similar device(s) and insert product experience code were reviewed.It was determined insert product experience code has not caused or contributed to any deaths or serious injuries within the time period of jan 1, 2018 ¿ july 11 2022.In total, there have been zero serious injuries and zero deaths reports related to insert product experience code in the last 4.5 years.Based on the data, the likelihood of a death or serious injury occurring as a result of the failure is remote; therefore, insert product experience code associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.
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Manufacturer Narrative
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Product complaint # (b)(4).All medical device reports associated with the same/similar device(s) and visual shaved/delaminated were reviewed.It was determined visual shaved/delaminated has not caused or contributed to any deaths or serious injuries within the time period of (b)(6) 2018 ¿ (b)(6) 2022.In total, there have been zero serious injuries and zero deaths reports related to visual shaved/delaminated in the last 4.5 years.Based on the data, the likelihood of a death or serious injury occurring as a result of the failure is remote; therefore, visual shaved/delaminated associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.
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Search Alerts/Recalls
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