Model Number 1221-36-054 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ossification (1428); Calcium Deposits/Calcification (1758); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Weakness (2145); Ambulation Difficulties (2544); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(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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Pinnacle medical records received.After review of the medical records, post revision clinical visit reported pain in left groin, lower back, weakness, numbness sensation, flexor tendinitis, bone loss in the proximal portion of the femur, local tissue reaction, ongoing iliopsoas tendinopathy.X-rays revealed heterotopic bony formation on the greater trochanter.Doi: (b)(6) 2018; dor: unknown; left hip.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
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Event Description
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Medical record received.Update ad (b)(6) 2022: (b)(4), has been reopened due to the receipt of pfs and medical record.Pfs alleges that patient has limitations when walking and limited movement of any physical activity.X-rays result stated that there is a fracture fragment seen lateral to the femoral neck.
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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.Added: b5, h6 (health effect - clinical code & health effect - impact code).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: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: 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).A manufacturing records evaluation (mre) was not performed.Corrected: g1.
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Search Alerts/Recalls
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