MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Information (3190)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: persona femur trabecular metal cr standard porous cat#: 42502806602 lot#: 62643713, persona articular surface fixed bearing cr cat#: 42522000510 lot#: 62493556, nexgen tm standard primary patella cat#: 00587806535 lot#: 62491771.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.These products are used for treatment.No devices were received; therefore, the device history records were reviewed for deviations and/or anomalies with no anomalies/deviations identified that are related to this event.However, as there is insufficient information to allow for selection of a root cause.Root cause is unknown.No corrective or preventive actions are needed at this time.Zimmer biomet will continue to monitor for trends.Product location is unknown.

Event Description

Revision due to instability.

Manufacturer Narrative

The complaint reported issues of migration and instability are confirmed, based on the revision operative notes.The devices were not returned for further examination.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.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.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Reported event was confirmed by review of medical records.Visual examination of the returned product identified foreign material in the tm on the femoral component and damage on the proximal side of the bearing.The dovetail feature was noted to be damaged, which appeared consistent with removal of the device.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Dhr was reviewed and no discrepancies were found.Per the persona knee system package insert (87-6204-021-23, rev.A), instability is a known potential adverse effect of this procedure.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) RIGHT 10 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7373448
• MDR Text Key: 103557687
• Report Number: 0001822565-2018-01797
• 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: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2020

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: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 42522000510
• Device Lot Number: 62493556
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 03/23/2018; 12/30/2019
• Supplement Dates FDA Received: 03/30/2018; 01/02/2020
• 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: 57 YR