Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problems
Hematoma (1884); Necrosis (1971); Joint Dislocation (2374)
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Event Date 12/07/2021 |
Event Type
Injury
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Manufacturer Narrative
|
(b)(4).
Concomitant medical products: zimmer cat# 01.
06010.
306 avenir stem lat cemented 6 lot# 3039253; zimmer cat# 00500105200 shell 52 mm o.
D.
Lot# 64892224.
Report source: foreign country: (b)(6).
Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03693.
|
|
Event Description
|
It was reported that patient underwent a left hip arthroplasty.
Subsequently, the patient was revised approximately 2.
5 weeks later due to dislocation.
It is believed that the original femoral component was cemented too proud.
The patient hip joint was believed to be too tight.
It was revised to a smaller size stem and placed with more anteversion.
Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
(b)(4).
Concomitant medical products: zimmer cat# 01.
06010.
306 avenir stem lat cemented 6 lot# 3039253; zimmer cat# 00500105200 shell 52 mm o.
D.
Lot# 64892224.
Report source: foreign country: (b)(6).
Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03693.
|
|
Event Description
|
It was reported that patient underwent a left hip arthroplasty.
Subsequently, the patient was revised approximately 2.
5 weeks later due to dislocation.
It is believed that the original femoral component was cemented too proud.
The patient hip joint was believed to be too tight.
It was revised to a smaller size stem and placed with more anteversion.
Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Search Alerts/Recalls
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