|
Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Limited Mobility Of The Implanted Joint (2671)
|
Event Date 11/08/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the devised remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 42538000401 63534512 partial tibial cemented size d left medial.42518200408 63424640 partial articular surface left medial size d 8.Multiple mdrs have been submitted for this patient.Mdr 0001822565-2020-03166.Mdr 0001822565-2020-03167.
|
|
Event Description
|
A patient had a left persona partial knee in (b)(6) 2017.Subsequently, at two years, the patient is experiencing pain and rom limited mobility requiring steroid injection.
|
|
Manufacturer Narrative
|
No devices or photos were received; therefore, the condition of the components is unknown.Review of the device history records identified no related deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history for part#42558000301, lot # 63461852 identified one additional similar for the reported item and no additional complaints for part and lot combinations.Complaints are monitored through monthly complaint review (reference (b)(4)) in order to identify potential adverse trends.Review of complaint history for part#42538000401, lot # 63534512 identified two additional similar for the reported item and no additional complaints for part and lot combinations.Complaints are monitored through monthly complaint review (reference sop040001 and wi040015) in order to identify potential adverse trends.Review of complaint or part#42518200408, lot # 63424640 found no additional related issues for this item and the reported part and lot combination.Crf report provided by the patient and states that no intra-op complications were seen during the primary surgery.The follow up appointments after his surgery from three month visit(on august 10, 2017) to two year follow up (june 11, 2019) state that patient had moderate pain and issues with range of motion.The patient was treated with steroid injection on june 11, 2019.This complaint is not confirmed.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Event Description
|
It was reported left initial total knee arthroplasty.Subsequently, 4 years post implantation, the patient reported severe pain.Patient was revised 5 months after the reported pain.The femur, tibia, articular surface, and pfj were exchanged.No operative report provided.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information. h6-component code- suggested code: mechanical (g04) - femur.Patient underwent revision left tka and components exchanged were femur, tibia, articular surface, and pfj.No operative report was provided.Health effect-impact code was updated to revision code.Root cause does not change from previous investigation.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
|
|
|