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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. CPLT F&A KIT 3CC 15G END; PROSTHESIS, KNEE

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ZIMMER KNEE CREATIONS, INC. CPLT F&A KIT 3CC 15G END; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)
Event Date 03/12/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent scp with an antegrade approach to inject the left calcaneum with 0.6cc of accufill reconstituted in saline.Concomitant procedures included a left peroneus brevis tendon repair, synovectomy, and hardware removal.The patient was treated for a 1-inch superficial non-healing wound with debridement in the clinic.The investigator labeled the event as possibly related to the surgical procedure, not related to the implant, and moderate in intensity.The event has been resolved.
 
Event Description
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.
 
Manufacturer Narrative
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
CPLT F&A KIT 3CC 15G END
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER KNEE CREATIONS, INC.
841 springdale drive
exton PA 19341
MDR Report Key10677200
MDR Text Key211254420
Report Number3008812173-2020-00020
Device Sequence Number1
Product Code OJH
UDI-Device Identifier00889024205352
UDI-Public(01)00889024205352(17)221111(10)KC06405
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/11/2022
Device Model NumberN/A
Device Catalogue Number514.315
Device Lot NumberKC06405
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/24/2020
Initial Date FDA Received10/14/2020
Supplement Dates Manufacturer Received10/19/2020
10/29/2020
Supplement Dates FDA Received10/21/2020
11/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age38 YR
Patient Weight94
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