|
Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problems
Bacterial Infection (1735); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Osteolysis (2377)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: catalog #: unknown, explor modular radial head replacement, lot # unknown.Report source: (b)(6).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: 0001825034-2020-01640.(b)(6).
|
|
Event Description
|
It was reported that initial right total elbow arthroplasty was performed approximately 3 years ago.Subsequently, the patient was revised about 3 months ago due to pain and swelling.During the revision, it was noted that the screw had backed out causing disassociation of the radial head and stem.What appeared to be metallosis was present throughout.All components were removed, and antibiotic beads were placed.The patient was treated for infection.No additional information available at this time.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).D11: medical product: catalog#: 11-210043, explor 14x24 mm implant head, lot#: unknown.Visual examination of the provided pictures identified the head, locking screw, and stem in a bag.The product appears to be cleaned and free of biomaterial.No further conclusions can be made regarding the condition of the product.Reported event was considered confirmed by the medical records that stated during the revision it was stated the locking screw had become disengaged and the soft tissue contained metallosis type coloring.From nine specimens sent for infection testing, one came back mildly positive.X-rays showed the radial head withdrawn from the radius partially and metallic fragment noted along the radial head inferiority.There were no fractures.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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
|
|
|