Model Number 1570-11-100 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/07/2021 |
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 mom litigation record received.Litigation alleges heavy metal poisoning from toxic heavy metals resulting to muscle, tissue injury, pain, metal wear, scar tissue formation, limited adl, emotional trauma and distress.Doi: (b)(6) 2013; dor: (b)(6) 2021; right 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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for 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.
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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.
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Event Description
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Medical records were received and stated the following: after review, patient was revised due to progressive soft tissue mass about his lateral hip and increasing pain.Laboratory studies were consistent with metollosis from his metal-bearing wear.There was a very large volume of hemorrhagic- and necrotic-appearing tissue.The surgeon initially worked to excise this, and had excised the pseudotumor, the surgeon identified the fascia, and the fascia was incised longitudinally.There was necrosis of the abductor complex.
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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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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.
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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.Through follow up it is now understood there is no allegation associated against a product malfunction.Review of the x-ray evidence found nothing indicative of a device nonconformance or a relation of the product with the reported adverse event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: b5.
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Event Description
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Medical records received indicate that on (b)(6) 2021: the patient developed a hematoma in the right hip requiring debridement and head and liner exchange.Iv antibiotics were given postoperatively.He is diagnosed with enterobacter septic arthritis.On (b)(6) 2021: the patient has had persistent wound drainage and elevated inflammatory markers since the (b)(6) 2021 i&d and a repeat aspiration revealed a deep hip infection.He underwent a revision on (b)(6) 2021 of all implants.During the removal of the stem, the calcar was fractured requiring two cables to fixate the bone.Postoperatively, excessive drainage from the wound occurred requiring a wound vac to be placed.On (b)(6) 2021: final implants are placed.An area of nonhealing of the previous incision was identified, though no intervention was noted.
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Event Description
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Medical records reviewed.(b)(6) 2007 left implant surgery (no specific info provided) on (b)(6) 2013 right implant surgery (no specific info provided) on (b)(6) 2021 the patient right total hip revision, for metallosis and pseudotumor.Revision of head and liner along with extensive debridement of necrotic muscle, fascia, and capsule.Patient was revised to a ceramic and polyethylene bearing.(no mention of manufacturer) on (b)(6)2021 the patient had a right re-revision with hematoma excision, irrigation and debridement with head and liner exchange (no specifics provided) on (b)(6) 2021, medical records note the patient had persistent drainage from the right hip wound.Thick drainage of thick yellow material since the last surgery on (b)(6)2021.On (b)(6) 2021, the patient had a right hip aspiration.On (b)(6) 2021, medical records notes that the patient reports having some pain in the right hip, there is some redness around the distal end of the incision.Drainage stopped (b)(6) 2021.On (b)(6) 2021 right extended recovery, revision surgery stage 1 due to infection.Patient underwent resection arthroplasty with placement of an antibiotic spacer.During the revision, significant purulent fluid and material was found.There was minimal attached bone, but there was a crack in the region of the calcar that was noted during extraction of femoral component.Cerclage cable was placed around calcar fracture proximally and then the stem was placed.On (b)(6) 2021 right revision surgery stage 2.The patient had a right total hip arthroplasty reimplantation as the patient had a cleared infection.Depuy components were implanted during hit procedure.
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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.On (b)(6) 2021, patient had a clinic visit and reported postoperative amount of surgical site drainage and evaluated.Has developed increasing pus type drainage, low-grade fevers of 100, increasing pain.Difficulty in walking.Pain is achy and sharp.Redness around the incision site.(b)(6) 2021, patient experience bleeding from incision site.On (b)(6) 2021, patient had pain in right hip and mass at the right hip.Patient lab results were on (b)(6) 2021, undergone right hip examination and findings of large palpable mass at the level of the trochanter in the lateral hip.Patient has elevated serum cobalt and serum chromium.
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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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Search Alerts/Recalls
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