MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA FIXED CEMENTED LEFT SIZE F STEM EXTENSION USE REQUIRED; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Off-Label Use (1494)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products : tem#: 42512100710; articular surface medial congruent (mc) left 10 mm height use with tibia sizes e-f/cr femur sizes 6-7; lot#: 64666577.Report source: foreign : (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00287.Reported event was confirmed by evaluation of returned associated device, as this device was not returned as it remains implanted in the patient.Device history record (dhr) was reviewed and no discrepancies were found.Per persona revision knee system ifu, it is stated do not use the persona revision femoral components or tibial plates with the persona cruciate retaining (cr), medial congruent (mc) or ultra congruent (uc) articular surfaces.Do not use the persona revision cck articular surfaces with the persona ps or cr femoral components.They are not designed to be compatible.Hence the root cause is attributed to off label use.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
It was reported that total knee arthroplasty was performed with persona.The surgeon could not insert persona mc surface to tibia base plate and he disengaged the surface to clean space between the surface and the tibia base plate by saline.After that, he tried to insert the surface again but he could not.Subsequently, persona uc surface was used to complete the procedure.

• Brand Name: TIBIA FIXED CEMENTED LEFT SIZE F STEM EXTENSION USE REQUIRED
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11327375
• Report Number: 0001822565-2021-00400
• Device Sequence Number: 11050645
• Product Code: JWH
• UDI-Device Identifier: 00889024562806
• UDI-Public: (01)00889024562806(17)290930(10)64495998
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42542007501
• Device Lot Number: 64495998
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/15/2021
• 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
• Outcome Attributed to Adverse Event: Other