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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 14 MM HEIGHT PROSTHESIS, KNEE

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ZIMMER, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 14 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rash (2033)
Event Date 07/05/2016
Event Type  Injury  
Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. This report is number 4 of 5 mdrs filed for the same patient (reference 3007963827-2017-00002 , 0002648920-2017-00027, 3007963827-2017-00003, 0001822565-2017-00307, & 0001822565-2017-00310).

 
Event Description

Patient alleged experiencing left knee rash approximately five months post-implantation. No additional information provided.

 
Manufacturer Narrative

Event date is unknown. Concomitant medical products- all poly patella cemented # 42540000029 lot # 63339813, femur cemented cruciate retaining (cr) narrow left # 42502006401 lot # 63092440, tibia cemented 5 degree stemmed left # 42532007101 lot # 63347843, palacos r 1x40 single # 00111214001 lot # 80364394. Reported event was unable to be confirmed due to limited information received from the customer. Device history record was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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.

 
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Brand NameARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 14 MM HEIGHT
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6267920
MDR Text Key65453272
Report Number0001822565-2017-00307
Device Sequence Number1
Product Code OIY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date10/31/2018
Device MODEL NumberN/A
Device Catalogue Number42512000514
Device LOT Number62500751
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/29/2013
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: 01/20/2017 Patient Sequence Number: 1
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