Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Blood Loss (2597)
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Event Date 04/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item# 00630505036 liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells lot# 63721280; item# 00784301606 femoral stem beaded fullcoat 12/14 neck taper std.Body std.Offset size 16 16 mm distal dia.160 mm length lot# 61601513; item# 00625006525 bone scr 6.5x25 self-tap lot# 61738462; item# 00625006530 bone scr 6.5x30 self-tap lot# 61724514; item# 00877703603 biolox⮠option, head, l, 㸠36/+3.5, taper 12/14 lot# 2911123.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0002648920 - 2019 - 00122; 0002648920 - 2019 - 00121; 0001822565 - 2019 - 00768; 0002648920 - 2019 - 00119.
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Event Description
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Patient underwent revision due to chronic infection approximately 7 years post initial hip arthroplasty, and approximately 3 months following previous intervention due to infection.All implants were removed and spacers implanted.Attempts were made to obtain additional information; however, none was available.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed by review of op notes which indicates patient was revised with antibiotic spacers due to left hip infection.All products were explanted.A blood loss of 800ml was noted.Spacers were implanted and desired stability was achieved.Device history record (dhr) was reviewed and no discrepancies were found.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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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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 during the revision, the patient experienced 800 ml of blood loss.Attempts have been made and no further information has been provided.
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Search Alerts/Recalls
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