MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL KNEE PROLONG HIGHLY CROSSLINKED POLYETHYLENE ALL POLY PATELLA SIZE 2 8MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 11/11/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices: natural knee gsf porous femoral component size 2 left, catalog #: 00541601501, lot #: 61015402; natural knee stemmed tibial component size 2 left, catalog #: 621200220, lot #: 61016120; natural knee ultracongruent articular surface 11mm size 1 2, catalog #: 00542801111, lot #: 60915866.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the patient underwent a left knee arthroplasty revision to address pain and ambulation difficulties secondary to patellar component loosening, dislocation and fracture approximately six (6) years post-operatively.Follow-up notes approximately six months prior to the revision state, "the patient is status post bilateral total knees approximately five and six years post-operatively with failure of the patella components bilaterally.Denies any history of trauma or any incident to bilateral knees, however, does complain of significant anterior knee pain, patellofemoral issues for the past week and is having difficulty and painful ambulation as well as pain with stairs, socks and shoes." revision operative notes state, "inspection of the knee revealed about 1-2+ laxity to varus valgus stress in both flexion and extension.Inspection of patella revealed that the patellar button was still attached to the patella with just 1 peg, and that one of the pegs had sheared off and was still in the bone and the second was still in the patellar component encased in cement.".

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

The product was evaluated through manufacturing review and radiographic inspection and the complaint was confirmed through review of medical records.The device history records were reviewed and no discrepancies relevant to the reported event were identified.A definitive root cause could not 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: NATURAL KNEE PROLONG HIGHLY CROSSLINKED POLYETHYLENE ALL POLY PATELLA SIZE 2 8MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8615329
• MDR Text Key: 145226480
• Report Number: 0001822565-2019-02044
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K071107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 00542000802
• Device Lot Number: 61057012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention