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Model Number CTA HUMERAL HEAD SHORT, 47MM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of Range of Motion (2032); Implant Pain (4561)
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Event Date 01/10/2023 |
Event Type
Injury
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Event Description
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It was reported that a 64 yo female patient, initial left shoulder implanted on (b)(6) 2022, underwent a revision procedure on (b)(6) 2023, approximately 5 months post the initial procedure.The hemi shoulder was converted to a reverse shoulder at the patient¿s request.The patient complained of no range of movement and pain on the left shoulder.The surgeon did a reverse on her other side, and she wanted her hemi converted to reverse to feel the benefits of the range of motion that she experiences with her other side.Patient was last known to be in stable condition following the event.The product is not returning as it was discarded by hospital.No further information.
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Manufacturer Narrative
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Concomitants: 7278662 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.7122028 300-10-45 - equinoxe replicator plate 4.5mm o/s.7273947 300-20-02 - equinox square torque define screw drive kit.Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Manufacturer Narrative
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After review of additional information received the following sections, have been updated accordingly: h6 based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to patient conditions.
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Search Alerts/Recalls
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