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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE INSERT, 3D EX SZ 6LT 9MM

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ENCORE MEDICAL L.P. 3DKNEE INSERT, 3D EX SZ 6LT 9MM Back to Search Results
Model Number 391-09-706
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 11/28/2018
Event Type  Injury  
Event Description
Revision surgery - due to an infection. Implants were removed and an antibiotic spacer was put in. Infection occurred caused by dental problems.
 
Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was a 2nd stage surgery to remove an antibiotic construct, used to alleviate a previous infection, and implant new components. Stage one consists of the removal of implants that are present in the infected joint, building a spacer to fill the joint and coating the spacer with antibiotics which is then implanted into the affected joint. The first stage surgery removed the parts listed in this complaint. Upon determination that the infection is under control and the tissue is normalized, stage 2, the antibiotic construct is removed and new components are implanted. The previous surgery and the surgery detailed in this investigation occurred over 2. 8 months apart. 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. There was no new information from the previous surgery regarding cultures identified in the infection, severity of the infection. The root cause of this complaint is a 2nd stage surgery to remove an antibiotic construct, used to alleviate a previous infection and implant new components. Said infection was reported to have been caused by dental problems. This event is not the result of a product deficiency, failure or issue.
 
Event Description
Revision surgery - the implants were removed and an antibiotic spacer was put in because an infection occurred caused by dental problems. This complaint is reporting the 2nd stage surgery to remove an antibiotic construct, used to alleviate the infection and implant new components.
 
Manufacturer Narrative
Corrected data: the main component reported on this complaint was inadvertently reported. Manufacturer narrative; the root cause of this complaint is a 2nd stage surgery to remove an antibiotic construct, used to alleviate a previous infection, and implant new components.
 
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Brand Name3DKNEE
Type of DeviceINSERT, 3D EX SZ 6LT 9MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
MDR Report Key8131047
MDR Text Key129295497
Report Number1644408-2018-01142
Device Sequence Number1
Product Code OIY
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,Followup
Report Date 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/28/2017
Device Model Number391-09-706
Device Catalogue Number391-09-706
Device Lot Number59602754
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/04/2018 Patient Sequence Number: 1
Treatment
233-01-106, LOT 890A1230; 333-01-106, LOT 271B1105
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