MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. NEXGEN FEMORAL COMPONENT OPTION SIZE D RIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Femoral component option size e right compatible with lps-flex prolong catalog #:00596401552 lot #: 63998082.(b)(6).Customer has indicated that the product will be returned to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple reports were filed for this event, please see associated reports: 3007963827 - 2021 - 00200.Investigation incomplete.
Event or Problem Description
It was reported that there was a mismatch between the packaging and the implant item label.The packaging says femoral right sz e and the sticker of implant says femoral right sz d.There was no patient involvement.Attempts have been made and no further information has been provided.
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.Updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, and h10.The results of the investigation are as follows: -visual examination of the returned product identified outer package and inner package with different product identification.-review of the device history record(s) identified no deviations or anomalies during manufacturing.-based on the information provided by the manufacturer, the devices were manufactured and packed with no issues, and the reported issue didn't happen when the product was in zb control; this was verified using the manufacturing record review.Therefore, we don't know how or when this mismatched issue happened.Thus, the root cause cannot be determined for this issue.However, we knew these two products were sent to the same customer based on the distribution record.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: NEXGEN FEMORAL COMPONENT OPTION SIZE D RIGHT
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12512382
• Report Number: 3007963827-2021-00203
• Device Sequence Number: 14744654
• Product Code: JWH
• UDI-Device Identifier: 00889024001107
• UDI-Public: (01)00889024001107(17)290531(10)64183501
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: P060037
• 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): 01/05/2022

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: 00596401452
• Device Lot Number: 64183501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• 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: 08/27/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2019
• 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: Prefer Not To Disclose