Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); Unequal Limb Length (4534)
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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: 0001825034 - 2023 - 00580, 0001825034 - 2023 - 00581, 0001825034 - 2023 - 00582, 0001825034 - 2023 - 00583, 0001825034 - 2023 - 00585, 0001825034 - 2023 - 00586, 0001825034 - 2023 - 00587.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported by the pmi group that a patient underwent right hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a pmi product on an unknown day due to leg length discrepancy.Attempts have been made and no further information has been provided.
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Event Description
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No further information 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 {update/corrected}.D10: cat# xl-108525 lot# 832500 arcomxl 40mm +3 hw lnr sz 25.Cat# 11-300916 lot# 937720 arcos 16x190mm spl tpr dist.Cat# 11-301324 lot# 836460 arcos con sz d std 70mm.Cat# 010001036 lot# 6726723 cocr fem hd 40mm type 1 -3mm.Cat# 00223200418 lot# 64629062 cable cerclage cable with crimp 1.8 mm dia.635 mm length.It was reported that one of the seven screws fractured.It is unknown which screw has fractured.
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Manufacturer Narrative
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No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the acetabular implant is loose and displaced superiorly as noted.Bone quality is osteopenic.All of the screws appear loose and an inferior screw is fractured.The resulting superior displacement of the arthroplasty would result in a limb length discrepancy.A definitive root cause cannot 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 further information at the time of this report.
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Search Alerts/Recalls
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