ZIMMER BIOMET, INC. +2MM LATERAL OFFSET 25MM POST LENGTH BASE PLATE; PROSTHESIS, SHOULDER, REVERSE CONFIGURATION
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Catalog Number 00434902502 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Rheumatoid Arthritis (1724); Erosion (1750); Failure of Implant (1924); Loss of Range of Motion (2032); Osteolysis (2377)
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Event Date 05/14/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01624, 0001822565-2023-01642.D10: item# 00434901013; lot# 63012698.Item# 00434903600; lot# 63028247.Item# 00434903611; lot# 63076788.G2: foreign - event occurred in the uk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The 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 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 the patient underwent a right shoulder arthroplasty approximately seven (7) years ago.Subsequently, at the patient's seven (7) year follow-up appointment, x-rays taken noted osteolysis in the humeral head, bone resorption, glenoid and humeral loosening.Patient has been taking pain relief medication, but no other intervention is planned due to severe rheumatoid arthritis and poor bone stock.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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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent reverse shoulder on (b)(6) 2016.Subsequently, on (b)(6) 2023, at 7-year follow-up appointment x-ray show osteolysis humeral head, bone reabsorption, glenoid loosening, and humeral loosening.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information 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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Search Alerts/Recalls
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