• 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. ARTICULAR SURFACE LPS/LPS-FLEX 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. ARTICULAR SURFACE LPS/LPS-FLEX PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395); Unstable (1667)
Patient Problems Fall (1848); Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 12/20/2016
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 based on allegations set forth in patient's complaint and the allegations contained therein are unverified. This is 2 of 4 reports being filed for the same patient (reference 1822565-2017-01008 / 01017 / 01018 and 2648920-2017-00075).

 
Event Description

It is reported that the patient was revised due to instability approximately 6 years post-implantation. Patient also reported that he couldn't step correctly, extreme loosening, falling, and pain. No further information has been provided.

 
Manufacturer Narrative

Medical devices - nexgen precoat stemmed tibial plate catalog #:00598005701 lot #:61451612, nexgen lps-flex option femoral femoral catalog #: 00596401751 lot #: 61496467, nexgen all-poly patella catalog #:00597206532 lot #: 61454218. The following section was corrected: f10: device code 1031 was mistakenly reported in the previous report. The complaint was confirmed based on the review of the surgical notes. No product was returned; visual and dimensional evaluations could not be performed. The device history records for the 00596205012, lot # 60523622 were reviewed and no deviations or anomalies were identified. The components were reviewed and no compatibility were noted. A complaint history search identified no other complaint for lot #60523622. The primary surgical notes state that the patient underwent tka to treat left knee osteoarthritis. After the bony cuts and sizing were completed the trial components were implemented and were found to demonstrate excellent range of motion, stability, and patellofemoral tracking. The trials were removed and the final components implemented. No complications noted. Reports of medical visit 5. 5 years after the primary surgery state that the left knee has been loosening over the last year and the patient complained of instability in the knee. Examination demonstrated significant varus/valgus deformity with varus/valgus laxity with at least 2 to 3 degrees of varus/valgus instability, and anterior/posterior laxity. The revision surgical notes, six years post-implantation, state that only the articular surface was replaced. According to the medical notes provided, the instability issue started four or more years after primary tka. Per the package insert of the articular surface, joint instability is a known potential adverse effect of the tka procedure. A definitive root cause cannot be determined with the information 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARTICULAR SURFACE LPS/LPS-FLEX
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 Key6344252
MDR Text Key67800904
Report Number0001822565-2017-01017
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK042271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date07/31/2011
Device MODEL NumberN/A
Device Catalogue Number00596205012
Device LOT Number60523622
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/25/2006
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: 02/20/2017 Patient Sequence Number: 1
-
-