MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE F 9MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant devices - persona partial cemented tibial component left medial size f catalog #: 42538000601 lot #: 64425554, persona partial cemented femoral component left medial size 5 catalog #: 42558000601 lot #: 64415265 the product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that when the surgeon attempted to seat a 9mm articular surface on the tibial tray and after several failed attempts, realized that the articular surface had been inserted upside down.Once the articular surface was confirmed to be the correct orientation, it was reinserted into the joint space, but could not be locked into place.Both the tibial component and articular surface were removed at that point and washed with an irrigation gun.It was confirmed that there was no cement or residue on the implants and the surgeon attempted to reinsert the articular surface with a blunt object, but was still unable to lock it in place.An 8mm articular surface was then used and the surgeon was able to insert it during the first attempt.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned articular surface exhibits damage to the locking feature.The locking feature is nicked, gouged and compressed.The dimensions for the returned device were verified and were found to be within specification.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The surgical technique states that with the engraved side of the articular surface implant down, slide the posterior edge of the polyethylene component under the posterior lip of the base plate.The compressed feature indicates that the device was not properly inserted.The root cause is attributed to use error.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 further event information available at the time of this report.

• Brand Name: PERSONA PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE F 9MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10333038
• MDR Text Key: 200630401
• Report Number: 0001825034-2020-02941
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304818309
• UDI-Public: (01)00880304818309
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42518200609
• Device Lot Number: 63756929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE