Catalog Number UNK HUMERAL HEAD |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
|
Patient Problems
Erosion (1750); Insufficient Information (4580)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01351 and 0001825034-2023-01353.D10: item# unknown glenoid base; lot# unknown.Item# unknown stem; lot# unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product 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.
|
|
Event Description
|
It was reported that the patient underwent a right shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a pmi custom implant for an unknown reason.No revision procedure has been reported to date.Attempts have been made and no further information has been provided.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6 upon reassessment of the reported event, it was determined to be not reportable as the patient has a vrs shoulder, in which a humeral component would not be implanted or involved in the reported event.The initial report was forwarded in error and should be voided.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
It was reported that the patient underwent a right shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a pmi custom implant due to bone loss.No revision procedure has been reported to date.Attempts have been made and no further information has been provided.
|
|
Search Alerts/Recalls
|