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Model Number 180552 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
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Patient Problems
Pain (1994); Limited Mobility Of The Implanted Joint (2671)
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Event Date 02/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: 115738 427050 compr nano hmrl pps 38mm; 115370 561960 comp rvs tray co 44mm; xl-115363 370710 arcom xl 44-36 std hmrl brng; 115310 827220 comp rvrs shldr glnsp std 36mm; 115330 881390 comp rvrs shdr glen bsplt +ha; 118001 223240 versa-dial/comp ti std taper; 115396 448270 comp rvs cntrl 6.5x30mm st/rst; 180551 046030 comp lk scr 3.5hex 4.75x20 st; 180551 046030 comp lk scr 3.5hex 4.75x20 st; 180551 670210 comp lk scr 3.5hex 4.75x20 s.Foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 - 00384, 0001825034 - 2021 - 00385, 0001825034 - 2021 - 00386, 0001825034 - 2021 - 00387, 0001825034 - 2021 - 00388, 0001825034 - 2021 - 00389, 0001825034 - 2021 - 00390, 0001825034 - 2021 - 00391, 0001825034 - 2021 - 00392, 0001825034 - 2021 - 00393.
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Event Description
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It was reported that the patient underwent an initial right reverse total shoulder arthroplasty.Subsequently, the patient has had on going issues of pain, noise (crepitus), and difficulty performing activities of daily living since the one-year visit.It is further reported the patient is scheduled for open biopsy to investigate the possible cause, such as possible underlying infection, currently remains implanted.No revision procedure has been reported to date.
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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, g3, g6, h1, h2, h3, h6, h10.Reported event was confirmed by review of radiographs/ medical records.Review of the available records identified the following: six week visit ¿ (b)(6) 2017.Radiographic evaluation ¿ no radiolucency, implant fracture, or migration.Zero notching.Six month visit ¿ (b)(6) 2017.Radiographic evaluation ¿ no radiolucency, implant fracture, or migration.Zero notching.One year visit ¿ (b)(6) 2018.Radiographic evaluation ¿ no radiolucency, implant fracture, or migration.Zero notching.Pain associated with poor activation.Two year visit ¿ (b)(6) 2019.Radiographic evaluation ¿ no radiolucency, implant fracture, or migration.Zero notching.Sclerotic line seen in proximal humerus three year visit ¿ (b)(6) 2021.Radiographic evaluation ¿ no radiolucency, implant fracture, or migration.Zero notching.Sclerotic line seen in proximal humerus.Unusual shoulder pain.Possibly procedure related.States device related.Listed for open biopsy right shoulder to investigate for infection.Blood taken for fbc, esr and crp- all negative.No revision has occurred.Device history record (dhr) was reviewed and no discrepancies 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional event information is available at the time of this report.
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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/corrected: b4; b5; g3; g6; h1; h2 upon receiving additional information of the reported event, it was determined to be not reportable.The report of noise/crepitus/catching are related to patient anatomy and not device.In addition, the device can be ruled out as causing/contributing to infection with conforming sterile certs.The initial report should be voided.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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