MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING (PS) LEFT 13 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Associated products : item#: 42512400212; articular surface fixed bearing (ps) left 12 mm; lot#: 63882917; item#: 42512400214; articular surface fixed bearing (ps) left 14 mm; lot#: 64078599; item#: 42532006101; tibia cemented 5 degree stemmed left size b; lot#: 63846640; item#: 42500605601; psn fem ps cmt ccr std sz 4 l; lot#: 64766049.Foreign : (b)(6).Customer had indicated that the product was being returned to zimmer biomet for investigation, but it has not yet been received.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 02856, 0001822565 - 2021 - 02859.
Event or Problem Description
It was reported that during an initial tka, the 13 mm persona ps surface would not fixate onto the tibial stem.Two other persona ps surfaces were trialed, 12mm and 14mm, and were also unable to be fixed onto the tibial stem.Alternatively, a 16 mm articular surface was used to complete the procedure.There was a delay of 16-30 minutes, with no consequence to the patient.Attempts have been made and no additional information has been provided.
Event or Problem Description
No additional information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, b5, d9, g3, h1, h2, h6 the reported event was confirmed by examination of the returned device.Visual inspection showed that the dovetail feature is slightly flared and the device exhibits signs of use, nicks and gouges.Review of the device history records identified no deviations or anomalies during manufacturing.A root cause could not 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 (PS) LEFT 13 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12568839
• Report Number: 0001822565-2021-02858
• Device Sequence Number: 3269568
• Product Code: MBH
• UDI-Device Identifier: 00889024236875
• UDI-Public: (01)00889024236875(17)221031(10)63827166
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42512400213
• Device Lot Number: 63827166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown