Model Number N/A |
Device Problems
Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)
|
Patient Problem
Pain (1994)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(6).The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.Halverson et al."clinical outcomes of biomet explor modular radial head arthroplasty system" journal title.37:853-858.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
|
|
Event Description
|
Information was received based on review of a journal article manuscript titled ¿clinical outcomes of biomet explor¿ modular radial head arthroplasty system¿ which aimed to explore short-term outcomes of surgery using the explor modular radial head arthroplasty system, manufactured by legacy biomet.One (b)(6) female was identified in the article that underwent radial head arthroplasty on an unknown date.Patient follow-up results provided at month 6 post-implantation indicates mild wrist pain, moderate elbow pain, type o loosening in ap and oblique radiographs.There has been no further information provided and the patient outcome is unknown.
|
|
Manufacturer Narrative
|
Reported event was unable to be confirmed as the lot number of device involved in the incident is unknown.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no were trends 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.Multiple mdr reports were filed for this event, please see associated reports: 1825034-2017-02383, 02707.
|
|
Search Alerts/Recalls
|