|
Catalog Number UNKNOWN |
Device Problem
Material Erosion (1214)
|
Patient Problem
Pain (1994)
|
Event Type
Injury
|
Event Description
|
It was reported that a patient underwent a left shoulder arthroplasty approximately thirteen (13) years ago.Subsequently, the patient has experienced severe pain over the past year.Lab tests indicate elevated chromium and cobalt levels.
|
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03295, 0001822565-2022-03296.Correction/removal number: medical products: item#: unknown, unknown humeral stem; lot#: unknown.Item#: unknown, unknown humeral tray; 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.
|
|
Event Description
|
It was reported that the patient has alleged that they are going to undergo a future revision procedure.However, no revision procedure has been reported to date.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03295-1, 0001822565-2022-03296-1.H6: component codes: mechanical (g04)- head.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A definitive root cause cannot be determined.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.
|
|
Search Alerts/Recalls
|
|
|