Model Number 1365-51-000 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Distress (2329); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)
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Event Date 05/10/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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.The device catalog number is unknown; therefore, udi is unavailable.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.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 mom litigation record received.Litigation alleges heavy metal poisoning from toxic heavy metal resulting to injuries, hip pain, metallosis, metal wear and limited adl.Plaintiff also suffered emotional trauma and distress.Plaintiff suffered subsequent dislocation post revision left hip.Doi: (b)(6) 2008; dor: (b)(6), 2022; left hip.
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Event Description
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Medical records received.After review of the medical records, the patient was revised to address failed left tha due to metal-on-metal severe metallosis and elevated metal ions.Operative note reported scarred tissue and synovial fluid.There was extensive dark gray reactive synovitis, pseudotumor tissues, and a mild amount of osteolysis around the femur.
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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.H10 additional narrative: added: a2 (age, dob), a3, b5, b7, d4 (lot, catalog, expiry date, udi), g4 (pma/ 510(k)), h4, h6 health effect - clinical code corrected: a1, d1, d2a, d2b, d10 (concomitant), g1.
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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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Event Description
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Medical records received.In addition to what was previously reported in the medical records patient had a disability and limited activity.The operative note reported scarred tissue flap of the posterior greater trochanter and found a moderately compromised dehisced posterior soft tissue envelope.The left leg is longer than the right by 7 mm and increased complexity, effort, and time due to the severity of the patient's pathology.Lab results for metal ions are above 7 ppb.Bilateral hip implant, however, the right hip had a competitor implant.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence found, nothing indicative of a device nonconformance.No signs of implant bearing wear were observed, on the provided evidence.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation (mre) will not be performed, since mom systems are obsolete.
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Search Alerts/Recalls
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