MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED (CPS); PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the articular surface would not assemble mating tibia plate.Another device was used to complete the surgery.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: tibia cemented stemmed catalog # 42532006401 lot # 66366497.G2: japan.H3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided.It was determined that this report is a duplicate of 3007963827-2024-00344.
Event or Problem Description
Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided.It was determined that this report is a duplicate of 3007963827-2024-00344.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED (CPS)
• 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: 20672550
• Report Number: 3007963827-2024-00453
• Device Sequence Number: 12588797
• Product Code: MBH
• UDI-Device Identifier: 00889024244535
• UDI-Public: (01)00889024244535(17)261215(10)65295264
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123459
• 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): 12/27/2024

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: 42522600614
• Device Lot Number: 65295264
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Prefer Not To Disclose