MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED (PS) STANDARD RIGHT SIZE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2- japan.H3- customer has indicated that the product will 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.
Event or Problem Description
It was reported when the packaging of a femoral was opened, something like lint or hair was seen in the sterile pouch.Back up implant was used to complete the procedure.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
Visual evaluation of the returned product found the packaging was previously opened.The device was returned with no packaging for review.No photos were provided of the alleged failure.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was returned opened.If any further information is received 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.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual evaluation of the provided photos found the sterile packaging was previously opened.A hair-like debris was identified.As the packaging was previously opened, the source of the debris cannot be confirmed.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was returned opened.If any further information is received 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: FEMUR CEMENTED (PS) STANDARD RIGHT SIZE 5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16768178
• Report Number: 3007963827-2023-00088
• Device Sequence Number: 3252832
• Product Code: JWH
• UDI-Device Identifier: 00889024229181
• UDI-Public: (01)00889024229181(17)321007(10)65492824
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113369
• 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,Followup
• Report Date (Section B): 08/02/2023

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 Model Number: N/A
• Device Catalogue Number: 42500605802
• Device Lot Number: 65492824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/25/2023
• Supplement Date Received by Manufacturer: 07/26/2023; 07/28/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 07/28/2023; 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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: Unknown