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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
Fever (1858); Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Localized Skin Lesion (4542); Swelling/ Edema (4577)
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Event Date 05/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) medical product: catalog #: 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 913310.Catalog #: 115396, comp rvs cntrl 6.5x30mm st/rst, lot # 074240.Catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 586200.Catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 761260.Catalog #: ti-115313, comp vrsdl glnspr 36mm +3 ti, lot # 580230.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01549, 0001825034-2021-01551, 0001825034-2021-01552, 0001825034-2021-01553, 0001825034-2021-01554.
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Event Description
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It was reported that the patient underwent a right shoulder revision procedure approximately 4 years post-implantation due to pain, loss of range of motion, and loosening of the components.Attempts have been made and there is no further information at this time.
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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, g3, g6, h2, h3, h6, h10.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event.Please see the associated reports (updated): ¿ 0001825034-2021-01549; ¿ 0001825034-2021-01551; ¿ 0001825034-2021-01552; ¿ 0001825034-2024-00891; ¿ 0001825034-2021-01553; ¿ 0001825034-2024-00892; ¿ 0001825034-2021-01554; ¿ 0001825034-2024-00893; ¿ 0001825034-2024-00894.Corrections to d1 and d2.D10: associated product information, part number (lot number): 010000589 (913310); 115396 (074240); 180553 (586200); 180553 (586200); 180551 (761260); 180551 (761260); ti-115313 (580230); 115340 (597650); xl-115363 (276000); an updated investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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Event Description
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It was reported that a patient with a known history of nickel allergy underwent a conversion from a right shoulder hemiarthroplasty to a reverse total shoulder arthroplasty due to rotator cuff deficiency with capsular contracture approximately nine years (9) and three (3) months ago.After implantation, the patient continued to have range of motion concerns, pain, swelling, low fevers, and skin lesions.After a negative infection workup, the patient was found to have an allergy to vanadium.The patient underwent explantation of all components approximately four (4) years and five (5) months later.During the procedure, there were no signs of loosening or infection.An osteotomy was required to remove the well-fixed stem.Cerclage wires were placed to stabilize the osteotomy, but no shoulder implants were inserted.No complications were reported as a result of the surgery.Attempts have been made, and no further information has been provided.
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Search Alerts/Recalls
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