Model Number 0132 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2022 |
Event Type
malfunction
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Event Description
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It was reported that the patient had an infection that required a wash out.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Manufacturer Narrative
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The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: infection.Probable root cause: design.Wrong raw material or manufacturing agent selected in-process cleaning not effective at removing manufacturing residuals not enough strict controls placed on raw material source and purity.Process: sterilization fault - including eto residuals.Contamination during manufacturing process; including endotoxins in-process cleaning not performed to spec (i.E.Residues and leachable dcm, ethanol and acetone).Application: contamination of instruments.Patient reaction/allergy sensitivity or with active/latent infection.Use of contrast media.Use of more than one implant within the shoulder.Wrong patient selection.The device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.Correction: the incorrect fda registration number was used during the initial report.The correct fda registration number is (b)(4).H3 other text: 81.
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Event Description
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It was reported that the patient had an infection that required a wash out.
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Search Alerts/Recalls
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