ENCORE MEDICAL L.P ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 46, E-PLUS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED
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Model Number 521-07-246 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Implant Pain (4561)
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Event Date 06/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
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Event Description
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Revision surgery - due to pain.
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Manufacturer Narrative
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It was reported as, revision surgery: "patient presented to dr.With pain in their left shoulder a year and a half following a primary total shoulder procedure.Patient had slipped on the ice over the winter and tore their rotator cuff during the event.Dr.Revise the anatomic shoulder to reverse using the products on dt male 69" the actual length of in-vivo for the item(s) listed is unknown as the original surgery date was not provided or could be established.This investigation is limited in scope as only partial information was provided to djo surgical - austin for review.The revised item(s) was not returned for examination and the item and or lot number(s) was not provided.To adequately investigate this event, the part and lot number(s) are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported item(s) showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.
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