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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE; INSERT, 3D EX SZ 8RT 15MM

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ENCORE MEDICAL L.P. 3D KNEE; INSERT, 3D EX SZ 8RT 15MM Back to Search Results
Model Number 392-15-708
Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 12/07/2020
Event Type  Injury  
Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
Event Description
Revision surgery - due to poly wear.
 
Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as poly wear.The previous surgery and the surgery detailed in this event occurred is unknown.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at hospital and not made available to djo surgical for examination.A review of the device history record (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was no non- conforming material report (ncmr) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.The root cause of this complaint was reported as poly wear.There were no findings during this evaluation that indicate the reported devices were defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may also contribute to an event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
 
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Brand Name
3D KNEE
Type of Device
INSERT, 3D EX SZ 8RT 15MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445
MDR Report Key11105639
MDR Text Key224733513
Report Number1644408-2020-01214
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912121040
UDI-Public(01)00888912121040
Combination Product (y/n)N
PMA/PMN Number
K091956
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number392-15-708
Device Catalogue Number392-15-708
Device Lot Number357G1051A
Was Device Available for Evaluation? No
Date Manufacturer Received03/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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