MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA THE PERSONALIZED KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	42542007901
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure approximately one (1) year and nine (9) months post-implantation due to loosening of the implants and reported pain.The implants were found to be loose but well-adhered to the cement mantle.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# (b)(6) ; lot# 64620016; item# (b)(6) ; lot# 65028876; item# (b)(6) ; lot# 64628788; item# (b)(6) ; lot# 64783312; item# (b)(6) ; lot# 64859452; item# (b)(6) ; lot# 64629414; item# (b)(6) ; lot# 65028876; item# (b)(6) ; lot# 65335632; item# (b)(6) ; lot# 64403866; item# (b)(6) ; lot# 60041062; item# (b)(6) ; lot# 60041062; item# (b)(6) ; lot# 60041062; item# (b)(6) ; lot# 60041062; item# (b)(6) ; lot# 60041062.G2: foreign - event occurred in australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h4; h6; h10.No product was returned.Photograph provided shows explanted devices showing bony in growth on it.X-rays provided were reviewed and not submitted to mmi at this time as they are undated and it would be difficult to correlate to the onset of the alleged loosening and loosening can be difficult to assess from a single time point image.Review of device history records identified no related deviations or anomalies during manufacturing for all the reported devices.A definitive root cause cannot be determined.This complaint cannot be confirmed.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA THE PERSONALIZED KNEE SYSTEM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: 19468928
• Report Number: 0001822565-2024-01895
• Device Sequence Number: 7498130
• Product Code: JWH
• UDI-Device Identifier: 00889024562813
• UDI-Public: (01)00889024562813(17)310310(10)64960930
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 11/12/2024

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 Catalogue Number: 42542007901
• Device Lot Number: 64960930
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2021
• 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: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 93 KG