• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. SEGMENTAL ARTICULAR SURFACE SIZE B 26MM PROSTHESIS, KNEE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER, INC. SEGMENTAL ARTICULAR SURFACE SIZE B 26MM PROSTHESIS, KNEE Back to Search Results
Catalog Number 00585002026
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2017
Event Type  malfunction  
Manufacturer Narrative
Complaint sample was evaluated and the reported event was not confirmed. Visual evaluation of the returned articular surface identified no cosmetic problem. Dimensional inspection found that the thickness at the lowest point of the condylar surface, the overall thickness, and the lateral width were all within tolerance. The antero-posterior width was found to be out of tolerance (larger than the maximum specified dimension) but the device was autoclaved prior to its return, which could have altered the dimensions. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. The size c 26mm trial and the size b 26mm final have the same thickness at the lowest point of the condylar surface, however, their overall thickness as well as the radii of curvature of the condylar surfaces are very different. The surgical technique clearly states to "insert the appropriate size articular surface provisional", when performing trial reduction. Therefore, it was concluded that user error is the root cause of the reported issue. A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device. 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.
 
Manufacturer Narrative
(b)(4). (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation is completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during a knee arthroplasty, the surgeon replaced the c trial and began to insert the size b 26mm implant. The surgeon realized that the insert was not the correct size as it was labeled to be and this caused a delay of one hour.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSEGMENTAL ARTICULAR SURFACE SIZE B 26MM
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 Key6704875
MDR Text Key249060501
Report Number0001822565-2017-04710
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PK070978
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Catalogue Number00585002026
Device Lot Number62614697
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/11/2017 Patient Sequence Number: 1
-
-