Model Number 1218-87-352 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arthritis (1723); Erythema (1840); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 07/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # : (b)(4).E3 initial reporter occupation: lawyer.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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Medical records : on follow-up visit: (b)(6) 2021: 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.Doi: (b)(6) 2013 ( cup and stem ), doi: (b)(6) 2021 ( head and liner ), dor: (b)(6) 2021, affected side: right hip.This pc is linked to (b)(4) ( main pc ).
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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.Review of the x-rays evidence found nothing indicative of a device nonconformance or a relation between the product and the reported 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.
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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.H10 additional narrative: added: b5, h6 (clinical code) 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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On follow-up visit: (b)(6) 2021: 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.On follow-up visit: (b)(6) 2021 patient had failure of the right total hip arthroplasty on (b)(6) 2021.Patient did well initially and was up and walking upon going home, but then patient developed swelling of the right hip followed by bleeding through the incision on (b)(6) 2021.Doi: (b)(6) 2013 ( cup and stem ) doi: (b)(6) 2021 ( head and liner ) dor: (b)(6) 2021 affected side: right hip.
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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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The patient had failure of the right total hip arthroplasty on (b)(6) 2021.Patient did well initially and was up and walking upon going home, but then patient developed swelling of the right hip followed by bleeding through the incision on (b)(6) 2021.Medical records received stated that on 28-apr-2021: patient has a head and liner exchange for a hematoma and they give iv antibiotics.He is diagnosed with enterobacter septic arthritis.On (b)(6) 2021, the wound continues to drain and a deep hip infection is identified, so he has a revision of all implants.
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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 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.
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Search Alerts/Recalls
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