MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD LEFT SIZE 10; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and 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 an initial tka, the sales rep opened the implant and noticed debris.The implant was removed from the field and there was no impact to the patient.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.Visual inspection of the returned femoral implant confirms that there is white material present on the distal surface of the implant.Attenuated total reflectance (atr) fourier transform infrared spectroscopy (ftir) measurements were performed in a portion of the particle which was removed from the femoral component.The spectra of the particle was consistent with a wax material, identified by the consistency of the particle.The specific type of wax could not be identified as the particle is likely a combination of wax and other materials.The dhr was reviewed and no discrepancies relevant to the reported event were found.Through the 6m investigation and material review no root cause for this issue has been identified.This investigation has determined that is highly improbable that the debris identified on the affected sample originated within the zoml process.Also, this investigation has shown that if the debris did originate within the zoml process that it is highly improbable that it would not be removed or detected through the cleaning and inspection processes.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD LEFT SIZE 10
• 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: 9321170
• Report Number: 3007963827-2019-00319
• Device Sequence Number: 345383
• Product Code: JWH
• UDI-Device Identifier: 00889024229273
• UDI-Public: (01)00889024229273
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: 42500606801
• Device Lot Number: 64256693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1