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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Osteopenia/ Osteoporosis (2651)
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Event Date 01/15/2024 |
Event Type
Injury
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Event Description
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It was reported the patient was revised for pain, effusion, and suspected implant loosening, as radiolucency was noted around the femoral component.The femoral implant and articular surface were revised.
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Manufacturer Narrative
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(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs.183073 vanguard cr por fmrl-lt 72.5 lot# 454790.Mdr: 0001825034-2024-00298.Additional associated products.185290 vngd ssk 360 l fem 80mm lot# 6495422.148328 bmt splined knee stm v2 14x160 lot# 400340.185410 vg 360 dst fm ag 80x10 ll/rm lot# 082110.185390 vg 360 dst fm ag 80x10 rl/lm lot# 606040.
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Search Alerts/Recalls
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