MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR CEMENTED STANDARD; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical product: tibia fixed cemented catalog # 42542006701 lot # 65262805, psn 2.5mm female scr 25mm 2pk catalog # 42-5099-025-25 lot # 65259757, headless trocar drill pin 75mm catalog # lot # catalog # 00-5901-020-00 lot # 65245936, 3.5mm hex headed screw x 48mm catalog # 00-5901-035-48 lot # 65307237, psn all poly pat ply 35mm catalog # 42-5400-000-35 lot # 65271003, pers rev 3mm off stem 15x135 catalog # 42-5603-135-15 lot # 64799486, pers rev 3mm off stem 16x135 catalog # 42-5603-135-16 lot # 64891211, psn rev tib fix np sz d r catalog # 42-5420-067-02 lot # 65114284, psn rev fem cmt ccr std sz 3r catalog # 42-5046-054-02 lot # 64867229, psn asf cps 18mm ve r 3-5 cd catalog # 42-5226-004-18 lot # 64917506.Reporter had indicated that product will not be returned.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 during a revision procedure, the surgeon mistakenly opened left implants which were implanted into the patient.The error was noticed after impacting the components.All components were removed without additional bone loss or complications, and the correct right sided implants were placed.Attempts to obtain additional information have been made; however, no more is available.
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, g3, g6, h1, h2, h3, h6, h10 reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to user error.Medical records review indicates that left femoral and left tibial implants assembled and implanted, noticed it did not look correct, quickly removed the left sided implants without loss of bone and the right sided femoral and tibial components were implanted.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: FEMUR CEMENTED STANDARD
• 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: 14220842
• Report Number: 0001822565-2022-01241
• Device Sequence Number: 11868729
• Product Code: JWH
• UDI-Device Identifier: 00889024562516
• UDI-Public: (01)00889024562516(17)300912(10)64862190
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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: 42504605401
• Device Lot Number: 64862190
• 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: 04/06/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2020
• 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: Female