MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE EF 12 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	00596403212
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial total knee arthroplasty, the articular surface would not mate with the tibial tray.There was a surgical delay of thirty (30) minutes after multiple attempts at implantation however the surgery eventually needed to be completed with a second device of the same size.There was no patient impact as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).D10: medical product: stemmed tibial component precoat size 3: catalog#00598003701, lot#65847053.G2: foreign: china.The product has been received by zimmer biomet and the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the returned product and provided pictures show that the dovetail feature is compressed and flared.Damage to the dovetail feature confirms the implant would not be able to seat.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event was due to use error.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.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

• Brand Name: ARTICULAR SURFACE SIZE EF 12 MM HEIGHT
• Common Device Name: PROSTHESIS, 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: 17624124
• Report Number: 0001822565-2023-02252
• Device Sequence Number: 14982139
• Product Code: JWH
• UDI-Device Identifier: 00889024634930
• UDI-Public: (01)00889024634930(11)230323(17)280321(10)65940043
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

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 Catalogue Number: 00596403212
• Device Lot Number: 65940043
• Was Device Available for Evaluation?: Yes
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Age: 68 YR
• Patient Sex: Prefer Not To Disclose