MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT SIZE 5; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Erosion (1214); Unstable (1667)

Patient Problems Pain (1994); Swelling (2091); Synovitis (2094); Reaction (2414)

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: articular surface with hinge post extension screw enclosed do not discard size f 12 mm height, femoral component for cemented use only size f left catalog 00588001601 lot 61871353, all poly patella size 32 mm dia.Standard 8.5 mm thickness catalog 00597206532 lot 62034479.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02444, 0001822565-2019-02445, 0001822565-2019-02446.

Event Description

It was reported that the patient underwent a revision procedure approximately seven years post implantation due to swelling, pain, elevated levels of co and cr in his blood after which the knee was judged as unstable.During the revision thick gray/ black fluid was noted; the surgeon noted that hypermobility may have caused stress on the hinge possibly contributing to the patient's high cobolt chromium levels.The articular surface, hinge pin, and tibial bushing were removed and replaced.

Event Description

Additional information received.

Manufacturer Narrative

Reported event was confirmed by review of medical records.X-ray review showed slight angulated orientation of the hinge upon the tibial plate in the ap view suggesting the hinge mechanism has failed.The knee is positioned in slight valgus orientation, with angulation greatest at the level of the hinge.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information reported.

• Brand Name: TIBIAL COMPONENT PRECOAT SIZE 5
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8692651
• MDR Text Key: 147772913
• Report Number: 0001822565-2019-02446
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00588000500
• Device Lot Number: 62057301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2019
• 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
• Patient Age: 43 YR