Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Unspecified Infection (1930); Skin Irritation (2076)
|
Event Date 09/24/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Additional concomitant medical products: 00875200932 crosslinked liner 63986950 00801803202 verys femoral head 64044387 00875705002 multi hole shell 64033374 00625006535 trilogy bone screw 64034587 (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05456; 0002648920-2018-00719; 0001822565-2018-5459; 0002648920-2018-00720.
|
|
Event Description
|
It was reported a patient underwent a right total hip arthroplasty, subsequently the patient underwent debridement, all implants were removed and cement spacer mold was implanted less than one month post operatively due to infection.Attempts have been made and no further information has been provided.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|