MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION CONSTRAINED CONDYLAR KNEE ARTICULAR SURFACE RIGHT 16MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Joint Laxity (4526)
Date of Event	01/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona revision fixed cemented tibia right size c catalog #: 42542006402, lot #: 65982591, persona revision cemented standard femur right size 7 catalog #: 42504606202, lot #: 66099367.G2 - report source - foreign: the event occurred in japan.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.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 the patient underwent a knee arthroplasty revision approximately four (4) months post-operatively to address post-operative fracture of the articular surface, pain and suspected infection.The wound was debrided and articular surface replaced.The explanted articular surface was noted to have a crack at the base of the post.Attempts have been made; however, no additional information is available.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified signs of being implanted with wear on the proximal surface, the distal surface of the locking feature were flared, and the post is cracked.-the device history record was reviewed and identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined for the implant fracture.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h6, h11.As stated in the instructions for use contraindications include, 'severe instability secondary to the absence of collateral ligament integrity'.It was known at the time of implantation that the patient experienced lcl ligament dysfunction, and as a result, the implant should not have been used.The root cause of the reported issue is attributed to user error.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 REVISION CONSTRAINED CONDYLAR KNEE ARTICULAR SURFACE RIGHT 16MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18611409
• Report Number: 0001822565-2024-00248
• Device Sequence Number: 2368764
• Product Code: JWH
• UDI-Device Identifier: 00889024555150
• UDI-Public: (01)00889024555150(17)240630(10)64365806
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 09/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 42522800516
• Device Lot Number: 64365806
• 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: 01/05/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 08/26/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 06/04/2024; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose