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Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Adhesion(s) (1695); Cyst(s) (1800); Inflammation (1932); Pain (1994)
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Event Date 08/09/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Product code: phx.Concomitant medical products: 115370, comp rvs tray, 987730.Xl-115363, hmrl brng, 083700.115310, comp rvrs shldr glnsp, 036770.113651, comp primary stem, 658090.118001, comp ti std taper, 022770.180553, comp lk scr, 3.5hex 586200.180509, comp non-lckng screw, 931620.180503, comp locking screw, 120540.180503, comp locking screw, 424160.115382, comp rvs cntrl scr, 714480.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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 - 2021 - 02436.0001825034 - 2021 - 02437.0001825034 - 2021 - 02438.0001825034 - 2021 - 02440.0001825034 - 2021 - 02441.0001825034 - 2021 - 02442.0001825034 - 2021 - 02443.0001825034 - 2021 - 02444 0001825034 - 2021 - 02445.0001825034 - 2021 - 02446.
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Event Description
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It was reported by patients legal counsel that the patient underwent a left total shoulder arthroplasty revision procedure approximately six (6) years post-implantation due to pain, loss of range of motion, and loosening of the components.Attempts have been made and no further information has been provided.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g1-2, g3, g7, h1, h2, h6, h10 corrected: h4 if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported patient underwent a revision procedure due to an axillary cyst that was found that communicated to bone/joint.All hardware was removed.Irrigation and debridement of joint space and cyst with cement spacer & drains were placed.During the procedure surgeon had difficulty removing 2 stripped screws, but were explanted without indication of retained products.
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Search Alerts/Recalls
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