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

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Insert (1316)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that an articular surface would not seat with the tibial tray.There is no additional information available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot 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.
Event or Problem Description
No further event information available 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: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10 h6- health impact - clinical code- no known impact or consequence to patient is n/a which was reported on initial report.Type of investigation - device not returned is n/a which was reported on supplemental report.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of use and the dovetail feature is flared and compressed.The root cause is attributed to use error.The contact was sent the investigation results.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 HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10938049
• Report Number: 0001822565-2020-03974
• Device Sequence Number: 791529
• Product Code: JWH
• UDI-Device Identifier: 00889024211940
• UDI-Public: (01)00889024211940
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/22/2021

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: 64594519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 12/14/2020; 02/24/2021; 04/21/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 12/30/2020; 02/26/2021; 04/23/2021
• 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