MAUDE Adverse Event Report: ZIMMER, INC. ARTICULAR SURFACE LPS/LPS-FLEX; PROSTHESIS, KNEE

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.

• Brand Name: ARTICULAR SURFACE LPS/LPS-FLEX
• Type of Device: PROSTHESIS, 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 Key: 6344252
• MDR Text Key: 67800904
• Report Number: 0001822565-2017-01017
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• 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 Received: 02/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 00596205012
• Device Lot Number: 60523622
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 104