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

Model Number	N/A
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE F 9MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10333038
• Report Number: 0001825034-2020-02941
• Device Sequence Number: 3222811
• Product Code: HSX
• UDI-Device Identifier: 00880304818309
• UDI-Public: (01)00880304818309
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE