Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Unspecified Infection (1930); Pain (1994); Swelling (2091)
|
Event Date 08/26/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the hospital will no permit it.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: foreign (b)(6).
|
|
Event Description
|
It was reported that the patient underwent an initial left knee arthroplasty due to osteoarthritis.Subsequently, the patient experienced redness, swelling, pain in the knee joint, and ulceration and pus on the wound 11 months after the procedure.The patient was admitted to the hospital and cultured as candida albicans in joint puncture fluid and diagnosed as periprosthetic infection.The patient underwent a partial revision for debridement of the infected joint.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.D11: item # 183132 lot # j608738.Item # 141235 lot # j6184051.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no related deviations or anomalies during manufacturing.Medical records were not provided.Root cause cannot 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.
|
|
Search Alerts/Recalls
|