Catalog Number 01.32.154DH |
Device Problem
Device Appears to Trigger Rejection (1524)
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Patient Problem
Unspecified Infection (1930)
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Event Date 11/14/2023 |
Event Type
Injury
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Manufacturer Narrative
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Batch review performed on 20 november 2023: lot 1811190: (b)(4) items manufactured and released on 21-mar-2019.Expiration date: 2024-03-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional items involved in the complaints, batch review performed on 20 november 2023: liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot.1903449 lot 1903449: (b)(4) items manufactured and released on 23-may-2019.Expiration date: 2024-05-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Ball heads: cocr 01.25.031 cocr ball head 12/14 ø 36 size m 0 (k080885) lot.1902383 lot 1903234: (b)(4) items manufactured and released on 17-jul-2019.Expiration date: 2024-07-07.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Stem: amistem p 01.18.435 amistem-p collared std stem size 5 (k173794) lot.1903234 lot 1902383: (b)(4) items manufactured and released on 28-aug-2019.Expiration date: 2024-08-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
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Event Description
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At about 4 years from the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon explanted all implants and placed an antibiotic spacer for a 2-stage infection protocol.The surgery was completed successfully.
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Event Description
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At about 4 years from the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon explanted all implants and placed an antibiotic spacer for a 2-stage infection protocol.The surgery was completed successfully.On (b)(6) 2024, permanent implants were placed (about 4 years and 2 months after the primary surgery).
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Manufacturer Narrative
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Additional information reported in this follow up: - event description updated because we have been informed that permanent implants were placed on (b)(6) 2024.The new description is: at about 4 years from the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon explanted all implants and placed an antibiotic spacer for a 2-stage infection protocol.The surgery was completed successfully.On (b)(6) 2024, permanent implants were placed (about 4 years and 2 months after the primary surgery).
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Search Alerts/Recalls
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