MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE RGIHT 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The 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 during knee arthroplasty that when the articular surface implant was opened, the outer sterile plastic carton was deformed and the inner sterile paper cover was identified to not be sealed completely to the carton.The outer packaging exhibited no issues and was properly sealed.Another device was used to complete the procedure.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Visual evaluation of the returned packaging found that both of the sterile blistered exhibited damage visually consistent with thermal damage.Additionally, the inner sterile blister tyvek seal had lifted in one area.The device history records were reviewed and no discrepancies were identified.The condition of the device when it left zimmer biomet was considered non-conforming to specification.Based on the information provided and evaluation performed, the root cause of the reported event is attributed to packaging operator not following work instructions provided.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: PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE RGIHT 10MM
• 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: 20004892
• Report Number: 3007963827-2024-00315
• Device Sequence Number: 4953610
• Product Code: MBH
• UDI-Device Identifier: 00889024468412
• UDI-Public: (01)00889024468412(17)290214(10)66567479
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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: 42522100810
• Device Lot Number: 66567479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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
• Patient Sex: Male