Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Impaired Healing (2378)
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Event Date 02/21/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 211222 compr srs tumor bdy - 61mm 538540; 211227 compr srs ic seg - 120mm 121650; 211228 compr srs mod rgx aug - sm 301880; 211278 compr srs seas hmrl head 48x19 241330.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, 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 - 2019 - 01212; 0001825034 - 2019 - 01214; 0001825034 - 2019 - 01215; 0001825034 - 2019 - 01220.
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Event Description
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It was reported that a patient had comprehensive srs hemiarthroplasty placed in the right shoulder.Subsequently, the patient experienced wound drainage during staple removal two (2) weeks post implantation.The patient was treated with prophylactic antibiotics.
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Event Description
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Upon reassessment of the reported event based on additional information received, it was determined the event was not a complaint.Hence the initial report submitted needs to be voided.
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Manufacturer Narrative
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Upon reassessment of the reported event based on additional information received, it was determined the event was not a complaint.Hence the initial report submitted needs to be voided.
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Search Alerts/Recalls
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