MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA NATURAL TRIBECULAR METAL TWO-PEG POROUS FIXED BEARING L SZ D; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Unequal Limb Length (4534)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - femur trabecular metal cruciate retaining (cr) standard porous catalog #: 42502806201 lot #: 64681652; articular surface fixed.Bearing cruciate retaining (cr) left 10 mm height catalog #: 42512000110 lot #: 64585775; all-poly patella cemented32 mm diameter catalog #: 42540200032 lot #: 64776017.Report source - foreign: (b)(6).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.Investigation incomplete.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision due to pain, limb malalignment and tibial subsidence approximately three months post-operatively.Initial operative notes did not identify any intraoperative complications.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b7, d4,h1, and h10.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
Revision operative notes note that a revision was performed for tibial subsidence.The implants were removed and no intraoperative complications were reported." mmi final report received and attached to xrays within complaint.Tibial subsidence and radiolucency confirmed with questionable loosening.
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.No product was returned or pictures provided; a visual and dimensional evaluations could not be performed.The review of the device history record(s) identified no deviations or anomalies during manufacturing.The device is used for treatment and the reported products were reviewed for compatibility with no issues noted.A review of complaint history found no additional related issues for this item and the reported part and lot combination.X-rays were provided and reviewed by a health care professional.Review found left total knee arthroplasty with evidence of anterior and medial tibial subsidence with radiolucency seen along the cement hardware interface of the lateral tibia.Possible loosening along the lateral tibial plateau and small joint effusion.There was normal overall fit and sizing.Review of the provided medical records found all components were removed without complication and further medical records were not provided.A definitive root cause cannot be determined and no corrective actions, preventive actions, or field actions resulted after investigation of this event.This complaint was confirmed.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: PERSONA NATURAL TRIBECULAR METAL TWO-PEG POROUS FIXED BEARING L SZ D
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11301570
• Report Number: 0001822565-2021-00341
• Device Sequence Number: 19018035
• Product Code: JWH
• UDI-Device Identifier: 00889024510531
• UDI-Public: (01)00889024510531(17)300131(10)64561902
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2021

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 Model Number: N/A
• Device Catalogue Number: 42530006701
• Device Lot Number: 64561902
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 02/15/2021; 03/11/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 02/26/2021; 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: SE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 105