MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 11 MM HEIGHT; KNEE, PROSTHESIS

Catalog Number 42512000511

Device Problems Difficult to Insert (1316); Unstable (1667); Insufficient Information (3190); Migration (4003)

Patient Problem No Information (3190)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).All poly patella cat: 42540000032 lot: 62405046; trabecular metal femoral cruciate retaining cat: 42502806801 lot: 62614832; natural tibia trabecular metal fixed bearing 42530007501 lot: 62657581.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product not returned.

Event Description

It was reported that the patient was revised due to unknown reasons.Only the articular surface was revised.

Manufacturer Narrative

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.

Event Description

It was reported that the patient was revised due to instability, laxity and loosening, only the articular surface was revised.It was further reported that the surgeon had difficulty inserting the articular surface.

Manufacturer Narrative

Reported event was confirmed by review of op notes provided.Medical records indicate evidence of loosening, laxity, and instability.Further noted was mild synovitis and the poly was increased by two sizes.Finally, it was noted that the was difficulty initially with the flanges capturing posteriorly and eventually got it to lock in appropriately.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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.

Event Description

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

• Brand Name: ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 11 MM HEIGHT
• Type of Device: KNEE, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7659879
• MDR Text Key: 113065786
• Report Number: 0001822565-2018-03581
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2019

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: Physician
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 42512000511
• Device Lot Number: 62500748
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 09/13/2018; 04/01/2019
• Supplement Dates FDA Received: 10/09/2018; 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR