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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY SCP KIT

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ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY SCP KIT Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems No Information (3190); No Code Available (3191)
Event Date 11/30/2016
Event Type  Injury  
Manufacturer Narrative

The event was first brought to the attention of zimmer on nov 30, 2016 and was investigated. The complaint engineer was able to speak with a partner of the complainant, on march 16, 2017. The partner was familiar with and had reviewed the cases referenced by the complainant. The partner confirmed that several painful scp patients have been treated by the practice. Several of these patients had progressed on to total knee arthroplasty (tka). Additionally, the partner was not aware of any dead bone attributed to this complaint but did say the practice has an academic question regarding the impact of accufill on surrounding trabecular bone. He recognized the revised scp cases as being progression of disease. The initial report was filed under (b)(4) on april 25th, 2019 under mfr number 3008812173-2019-00024. The customer had indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. The investigation has been reopened for further investigation. Once the investigation has been competed, a follow-up mdr will be submitted.

 
Event Description

During a (b)(6) course in (b)(6), a distributor reported that a surgeon conversed about 8 scp cases as also evaluating the product in an unfavorable way. The distributor attending also reported that the surgeon went as far as to report he found numerous cases of dead bone after the scp procedures.

 
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Brand NameSUBCHONDROPLASTY
Type of DeviceSCP KIT
Manufacturer (Section D)
ZIMMER KNEE CREATIONS, INC.
841 springdale drive
exton PA 19341
Manufacturer (Section G)
ZIMMER KNEE CREATIONS, INC.
841 springdale drive
exton PA 19341
Manufacturer Contact
shari bailey
841 springdale drive
exton, PA 19341
4848794543
MDR Report Key8601532
MDR Text Key144756982
Report Number3008812173-2019-00027
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/30/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 05/10/2019 Patient Sequence Number: 1
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