Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Bone Fracture(s) (1870); Unspecified Infection (1930)
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Event Date 06/02/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: 802203202 zb 12/14 cocr hd 32mm x +0 2999580; 00800595232 acetabular cup for cemented use only id 32 mm snap-in od cup with spacers 55 mm 63608860; 00223200418 cable cerclage cable with crimp 1.8 mm dia.635 mm length 65573115; 00223200418 cable cerclage cable with crimp 1.8 mm dia.635 mm length 65576873.G2: foreign: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 the patient underwent a hip arthroplasty and was revised two months post implantation due to an underlying infection and subsequent femur fracture due to a fall.Attempts have been made and no further information has been provided.
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Event Description
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No further information is available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04)- stem no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records for the stem identified no deviations or anomalies during manufacturing.All sterile certifications for each device were conforming to specifications.Images assessed but not sent to mmi as the background of the or obscures the view of the implants in the xrays.Sending the images would not enhance the investigation.It was reported the patient suffered a femur fracture due to a fall.However, as the reason for the fall is unknown, a definitive root cause cannot be identified.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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Search Alerts/Recalls
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