Catalog Number 198722123 |
Device Problem
Fracture (1260)
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Patient Problems
Loss of Range of Motion (2032); Ambulation Difficulties (2544)
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Event Date 10/12/2020 |
Event Type
Injury
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Manufacturer Narrative
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(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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Hcp reported to (b)(6): emergency presentation to our emergency room because of twisting trauma tonight.The patient did not suffer a fall, she only twisted the knee.Subsequently it was no longer possible to tread.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary =no physical device was returned, however, photographs were provided confirming the reported fracture.The investigation findings did not indicate 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 =a worldwide lot specific complaint database search was not possible because the required product/lot combination was not provided.,the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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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: d10 and g4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2, d2b, d4 (catalog).
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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 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.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 = > no physical device was returned, however, photographs were provided confirming the reported fracture.The investigation findings did not indicate 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 = > a worldwide lot specific complaint database search was not possible because the required product/lot combination was not provided.,the returned device (lps tib hinge insert xsm 23mm, p/n: 198722123) does not have a valid, identifiable finished goods lot number, however alpha codes of the two individual subcomponents of the device were obtainable and device history records for the two sub-components were reviewed.Sub-component description: casting, hinge post, cocr, long part number: 6285100 alpha code: 6d93 dhr review: 1) quantity manufactured: 21 2) date of manufacture: november 8, 2007 3) any anomalies or deviations identified in dhr: none 4) expiry date: no expiry date is provided for the sub-component.Furthermore, due to no valid finished good lot code provided, it is not possible to determine the expiry date of the assembled device (p/n 198722123) 5) finished goods ifu reference: ifu-0902-00-773 sub-component description: polyethylene hinge uhmwpe #1050 part number: 8049369 alpha code: bfa00l6 dhr review: 1) quantity manufactured: 35 2) date of manufacture: july 20, 2007 3) any anomalies or deviations identified in dhr: none 4) expiry date: no expiry date is provided for the sub-component.Furthermore, due to no valid finished good lot code provided, it is not possible to determine the expiry date of the assembled device (p/n 198722123) 5) finished goods ifu reference: ifu-0902-00-773.
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Search Alerts/Recalls
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