DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX58OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
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Catalog Number 121887358 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Erosion (1750); Cyst(s) (1800); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Synovitis (2094); Tissue Damage (2104); Distress (2329); Injury (2348); Ambulation Difficulties (2544); Not Applicable (3189); No Code Available (3191)
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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 severe and constant pain, swelling, lack of mobility, damage to surrounding tissue and bone caused by inflammation, metallosis, metal toxicity,bone erosion and pseudotumors.It was also indicated that there was bursitis and emotional distress.The plaintiff seek compensatory damages.Doi: (b)(6) 2007; dor: not reported: left hip.
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Manufacturer Narrative
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(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 code(s) was not provided.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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Pfs and medical records received.Pfs alleges injury and pain in hip when walking and standing.After the review of medical records for mdr reportability, radiographs reported benign cystic change at the left supra acetabular ilium, and tiny amount of fluid or synovitis.Metal ion levels are below 7 ppb.There were no implant nor revision notes provided.
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Manufacturer Narrative
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Udi: (b)(4).
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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.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 code(s) was not provided.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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Search Alerts/Recalls
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