ZIMMER BIOMET, INC. OFFSET MODULAR HUMERAL HEAD 19 MM HEAD HEIGHT 46 MM SPHERICAL HEAD DIAMETER; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES
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Catalog Number 00430204619 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Osteolysis (2377); Osteopenia/ Osteoporosis (2651); Muscle/Tendon Damage (4532)
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Event Date 12/12/2023 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a right shoulder arthroplasty approximately fourteen (14) years ago.Subsequently, the patient underwent the first stage of a two-stage revision surgery approximately a month ago due to aseptic loosening of the implants.A cement spacer was implanted.The second stage of the revision will take place at a later date with new implants.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00138, 0001822565-2024-00139.D10: medical products: item#: unknown, unknown 16mm bf stem; lot#: unknown.Item#: unknown, unknown 46 keeled glenoid, lot#: unknown.G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital disposed of the product as biohazard.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.H6: component codes: mechanical (g04) - head.Visual examination of the provided pictures identified humeral head.No part or lot information was pictured.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the humeral implant fit is maintained.There is extensive osteolysis of the glenoid with a non-opaque implant.Loosening cannot be excluded.Alignment is abnormal with humeral implant elevation in relation to the glenoid.Bone quality is osteopenic.The root cause of the reported issue is attributed to no problem found as the head is not related to implant fixation.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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