MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING PS LEFT 10 MM HEIGHT; 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	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2021-00080.Medical devices: tibia cemented 5 degree stemmed left size d catalog#: 42532006701 lot#: 64761364 femur cemented posterior stabilized (ps) narrow right size 6 catalog#: 42500006002 lot#: 63897746 report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 a tibial insert and tray intended for a left knee were implanted in a right knee.No revision procedure has been reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed via compatibility check.The reported products were reviewed for compatibility and it was determined that the following implants are not compatible: left-sided tibial plate and left-sided articular surface used with right-sided femoral implant in the right knee.Device history record was reviewed and no discrepancies were found.Root cause of the reported issue due to the surgeon not following the instruction.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 FIXED BEARING PS LEFT 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 11784248
• Report Number: 3007963827-2021-00101
• Device Sequence Number: 19747616
• Product Code: JWH
• UDI-Device Identifier: 00889024234277
• UDI-Public: (01)00889024234277(17)270630(10)64345843
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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: 42511400510
• Device Lot Number: 64345843
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 05/13/2021
• 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