MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE EF 10 MM; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: china customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the liner does not assemble to the tibial tray as expected.There was no patient impact or harm reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  visual examination of the returned product identified sign of use with flared and compressed damage.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Insufficient information provided to perform a compatibility check.Medical records were not provided.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Detailed instructions for inserting the articular surface are provided in the surgical technique.Complaint confirmed based on the product evaluation.The root cause is attributed to use error.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE SIZE EF 10 MM
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17764925
• Report Number: 0001822565-2023-02537
• Device Sequence Number: 12555810
• Product Code: JWH
• UDI-Device Identifier: 00889024634992
• UDI-Public: (01)00889024634992(17)270916(10)65611276
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173057
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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 Model Number: N/A
• Device Catalogue Number: 00596404010
• Device Lot Number: 65611276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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 Age: 68 YR
• Patient Sex: Male