MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED TIBIAL COMPONENT PRECOAT SIZE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an articular surface would not seat with the tibial tray properly.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-00059.Concomitant medical product: articular surface size ef 12 mm height, item#: 00596404012, lot#: 64673615.Report source - (b)(6).Customer has indicated that the product will not 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.
Additional Manufacturer Narrative
Upon further investigation, it was determined that this item was reported in error.The articular surface is dovetailed.This is a user error with this part.Tibial plate was able to assemble with a different dove tail.The initial report was submitted in error and should be voided.
Event or Problem Description
Upon further investigation, it was determined that this item was reported in error.The articular surface is dovetailed.This is a user error with this part.Tibial plate was able to assemble with a different dove tail.The initial report was submitted in error and should be voided.

• Brand Name: STEMMED TIBIAL COMPONENT PRECOAT SIZE 5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13713732
• Report Number: 0002648920-2022-00051
• Device Sequence Number: 17761551
• Product Code: JWH
• UDI-Device Identifier: 00889024217607
• UDI-Public: (01)00889024217607(17)280731(10)64123541
• 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): 04/28/2022

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 Model Number: N/A
• Device Catalogue Number: 00598004701
• Device Lot Number: 64123541
• Was Device Available for Evaluation?: No
• 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: 12/24/2021
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 75 KG