Catalog Number UNK HIP ACETABULAR CUP |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
|
Patient Problems
Cardiac Arrest (1762); Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Myocardial Infarction (1969); Pain (1994); Tissue Damage (2104); Weakness (2145); Anxiety (2328); Depression (2361); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Pinnacle mom litigation records received.Litigation alleges pain, elevated metal ions level, joint effusion, muscle damage, muscle weakness, cardiomyopathy, heart attack and cabg surgery and emotional distress.Doi: (b)(6) 2005; dor: none reported; right hip.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Pfs alleges limping, pain, lower back stiffness, heart disease, inflammation, cardiac arrest, quadruple bypass surgery, anxiety, and depression.
|
|
Manufacturer Narrative
|
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 caused or contributed to the potential event described in this report.H6 patient code: no code available (3191) used to capture the walking difficulty, asystole, absence of treatment and musculoskeletal stiffness.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Ppf alleges metal wear, metallosis, stroke and loosening of cup.
|
|
Manufacturer Narrative
|
Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
|
|
Search Alerts/Recalls
|
|