ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14; HIP PROSTHESIS
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pulmonary Embolism (1498); Unspecified Infection (1930)
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Event Date 01/09/2023 |
Event Type
Injury
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Event Description
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It was reported that patient was evaluated in the er for pulmonary embolism receiving iv dye leading to anaphylactic shock and respiratory failure about two months after initial left total hip arthroplasty.During hospitalization patient was also diagnosed with an unknown infection.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: g7 osseoti multihole 50mm d, item#: 110010263, lot#: 65273694; bone scr 6.5x30 self-tap, item#: 00625006530, lot#: j7370441; bone scr 6.5x25 self-tap, item#: 00625006525, lot#: j7348344; g7 longevity high wall 32mm d, item#: 20123204, lot#: 64580191; femoral stem press-fit collarless 12/14 neck taper standard body extended neck offset size 13 138mm stem length cementless, item#: 00786401320, lot#: 65603489.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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The patient underwent an initial left total hip arthroplasty.Fourteen (14) days later, the patient had excessive drainage and hematoma requiring joint debridement.Approximately, one month later, the patient was evaluated in the er for pulmonary embolism receiving iv dye leading to anaphylactic shock and respiratory failure.The patient was initially treated with rocephin.However, it was noted that the patient did not have an anaphylactic shock to rocephin but to contrast dye resulting in respiratory failure, requiring intubation and admission to icu.The patient was sedated and intubated in icu.During hospitalization, it was reported that the patient was diagnosed with an unknown infection and discharged home.
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