ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER SYSTEM MINI HUMERAL TRAY; EXTREMITY IMPLANT
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Model Number N/A |
Device Problem
Malposition of Device (2616)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Fungal Infection (2419)
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Event Date 09/14/2023 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a shoulder arthroplasty approximately a year and a half ago.The implants were mispositioned and the patient experienced discomfort and pain.The patient also had limited range of motion.The implants were well fixated.Patient was revised last week, all implants removed, but a temporary cement spacer in-situ.Attempts have been made and there is no further information at this time.
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Manufacturer Narrative
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(b)(4).D10 - medical product: catalog #: 110031424, cr vivacit-e 36mm brng std, lot # 65007488 catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # j7147587 catalog #: 113629, comp primary stem 9mm mini, lot # 936530 catalog #: 110032410, comp aug mini bsplt w tpr sm, lot # 65172916 catalog #: 115395, comp rvs cntrl 6.5x25mm st/rst, lot # 414620 catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 265350 catalog #: 180554, comp lk scr 3.5hex 4.75x35 st, lot # 973040 catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 099360 catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 881060 g2: new zealand h3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.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: 0001822565-2023-02619, 0001825034-2023-02222, 0001825034-2023-02223, 0001825034-2023-02224 h3 other text : device was discarded.
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Manufacturer Narrative
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(b)(4).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 further reported that during the procedure, it was noted that a fungal infection was present.However, the surgeon noted that this was not a contributing reason for the revision procedure.
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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).The reported event is confirmed for incorrect placement/orientation per the original surgeon's confirmation and the mmi review.The reported event is not confirmed for infection.Radiographs were provided and identified the following: a reversetype right shoulder arthroplasty is present.The implant alignment and glenosphere position appear abnormal, especially on the oblique/lateral view, with suspected antero/inferior angulation of the glenosphere.The position and alignment would be best evaluated by ct or mri.Implant fit is maintained, however, there is malalignment as noted with apparent malposition of the glenosphere.Bone quality is mildly osteopenic.No signs of loosening, wear, radiolucency, or any other contributing factor that would cause issues with any of the components on the x-ray.No other concerns anatomically or with the implants that could contribute to the patient¿s pain and limited range of motion.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to use error, surgeon mispositioning implants.Infection: the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet devices; therefore, a review of the device history records will not be performed.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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