Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Abscess (1690); No Code Available (3191)
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Event Date 04/09/2008 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical devices: item# 11-363660 36mm cocr mod hd -6mm lot# 505940; item # 11-104056 m/h sld/apx hle rnglc shl 56mm lot# 569300; item# ep-105914 epoly 36mm ringlc lnr hw sz24 lot# 974060.Customer has indicated that the product will not be returned to zimmer biomet for investigation as device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08027; 0001825034 - 2018 - 08026; 0001825034 - 2018 - 08025.
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Event Description
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It was reported a patient underwent primary left total hip arthroplasty approximately 10 years ago.Patient experienced distal wound separation and a small amount of seropurulent material on an unknown date.Attempts were made to obtain additional information; however, none was available.
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Manufacturer Narrative
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(b)(4).The follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes provided.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.The root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported that a patient underwent primary left total arthroplasty.Subsequently, the patient had distal wound separation and a small amount of seropurulent material and stitch abscess a month after the primary.
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Search Alerts/Recalls
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