DEPUY ORTHOPAEDICS, INC. 1818910 ARTICUL/EZE BALL 32 +1 GR; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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Catalog Number 136521000 |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671)
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Event Date 05/03/2016 |
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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Pinnacle litigation received.Litigation alleges injury, pain, discomfort and tenderness, stiffness, decreased range of motion, difficulty rotating the hip joint, difficulty bearing weight, difficulty ambulating, loss of mobility, disfigurement, emotional distress, and mental anguish.Doi: (b)(6) 2006; dor: (b)(6) 2016; left hip.
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Manufacturer Narrative
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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.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. .
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Event Description
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Ppf alleges metallosis and metal wear.
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Manufacturer Narrative
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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.Udi: (b)(4).
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