(b)(4).
Product device code - moz.
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.
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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It was reported that a patient underwent a gel-one injection approximately seven (7) weeks ago.
Subsequently, patient has not experienced relief since the procedure, and reported an increase of pain approximately five (5) weeks post-injection.
Attempts have been made and no further information has been provided.
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