MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Positioning Failure (1158); Difficult to Insert (1316)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2019-00300.Concomitant medical products: tibia cemented 5 degree stemmed left, item#: 42532006701, lot#: 64219474.Report source - (b)(6).Customer has indicated that the product will 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.

Event Description

It was reported that, during a total knee arthroplasty procedure, an articular surface would not seat to the tibial tray.Although he removed debris and cement prior to inserting the surface, there was a lot of space between the articular surface and the tibial tray.A smaller articular surface was used to complete the procedure.There is no additional information at this time.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Visual examination of the returned articular surface identified that the dovetail feature exhibits damage (flared out) and the distal surface exhibits damage in the insertion slot.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot 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.

• Brand Name: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) LEFT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 9217717
• MDR Text Key: 169227430
• Report Number: 3007963827-2019-00299
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42512400412
• Device Lot Number: 63880324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1