|
Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problems
Chest Pain (1776); Myocardial Infarction (1969); Pain (1994); Distress (2329); Discomfort (2330); Neck Pain (2433)
|
Event Date 05/01/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).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.Concomitant medical products: unknown, unknown humeral liner, unknown; unknown, unknown glenoid head, unknown; unknown, unknown tm base plate, unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06523, 0001822565 - 2017 - 06524, 0001822565 - 2017 - 06525.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 total reverse shoulder implant surgery.Subsequently, the patient experiences pain radiating from upper arm, across shoulder joint, into upper chest, throat area, and neck area.Pain and severe discomfort occur nightly while sleeping, causing wakefulness and distress for approximately 15-20 minutes.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Concomitant medical products: 00434903611, tm reverse 36 mm glenosphere, 61600008.The 00434903603, tm rev hum poly lnr/inlays, 61521207.The 00434903811, tm reverse base plate, 61615217.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-06524-1, 0001822565-2017-06523-1, 0001822565-2017-06525-1.
|
|
Manufacturer Narrative
|
Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
|
|
|