Model Number 130742206 |
Device Problems
Naturally Worn (2988); Noise, Audible (3273)
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Patient Problems
Edema (1820); Fatigue (1849); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Weakness (2145); Joint Disorder (2373); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 06/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The patient was revised to address loosening of the glenosphere at the bone to implant interface.The glenosphere broke off at mid screw of the metaglene.Relevant components retrieved and re implanted with new implants.Original stem and epiphysis were stable and not affected by the broken glenosphere.Right shoulder.
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Manufacturer Narrative
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If the information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4) investigation summary: the device associated with this report was not returned to depuy synthes for evaluation, however a disc with x-rays was returned for investigation.Based on the observable evidence and the investigation perform on the glenosphere and metaglane audible sound is possible, confirming the reported allegation.However with the evidence provided it is unknown if the cup is worn.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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