Model Number N/A |
Device Problems
Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problems
Rheumatoid Arthritis (1724); Joint Dislocation (2374); Subluxation (4525)
|
Event Type
Injury
|
Event Description
|
It was reported that a patient has a reverse shoulder in situ that has failed due to patient rheumatoid condition.Further information provided indicates that the patient's humeral tray and glenoid are loose within the joint.No revision procedure has been reported to date.Attempts have been made and there is no further information at this time.
|
|
Manufacturer Narrative
|
(b)(4).D10 - medical product: catalog #: unknown, glenoid, lot # unknown.G2: uk.H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02613.
|
|
Manufacturer Narrative
|
(b)(4).D10 - medical product: catalog #: unknown, bearing, lot # unknown.Catalog #: unknown, head, lot # unknown.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03415.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Event Description
|
It was reported that a patient has a reverse shoulder in situ that has failed due to patient rheumatoid condition.Further information provided indicates that the patient's humeral tray and glenoid are loose within the joint.Additionally, the pmi request states the patient has had significant erosive changes in the bone as well as history of subluxation/dislocation and the tray disassociated from the stem.No revision procedure has been reported to date.Attempts have been made and there is no further information at this time.
|
|
Manufacturer Narrative
|
(b)(4).D10: medical product: catalog #: unknown, glenoid, lot # unknown.Catalog #: unknown, stem, lot # unknown.Catalog #: unknown, baseplate, lot # unknown.Catalog #: unknown, screw, lot # unknown x 5.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02613, 0001822565-2023-03088, 0001822565-2023-03089, 0001822565-2023-03090, 0001822565-2023-03091, 0001822565-2023-03092, 0001822565-2023-03093, and 0001822565-2023-03094.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.No other new information.Investigation and root cause remains unchanged.
|
|
Search Alerts/Recalls
|