MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TM TWO-PEG POROUS FIXED-BEARING TIBIAL COMPONENT RIGHT SIZE H; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Swelling/ Edema (4577)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - persona medial congruent articular surface right 10mm catalog #: 42522100910 lot #: 64473419, persona cruciate retaining standard porous femoral component catalog #: 42502807002 lot #: 64873370, persona all poly patella catalog #: 42540000041 lot #: 64775342.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 right knee arthroplasty revision to address pain, swelling, limited range of motion, ambulation difficulties and tibial implant loosening approximately one (1) year post-operatively.Initial operative notes did not note any intraoperative complications.At the patient's one-month post-operative visit, the patient reported increased pain and swelling after being very active and was advised to moderate his activity level.At the patient's nine-month post-operative visit, the patient reported worsening knee pain, swelling, limited range of motion, stiffness and loss of strength.The surgeon reported that the intraoperative findings during the revision were consistent with aseptic loosening of the tibial component.All components were removed and replaced.At the patient's one-month post-operative visit following the revision, the patient was reported to be improving.
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 device history records were reviewed and no discrepancies were identified.Medical records were provided and reviewed by a healthcare professional.A definitive root cause could not be determined with the information 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.

• Brand Name: PERSONA TM TWO-PEG POROUS FIXED-BEARING TIBIAL COMPONENT RIGHT SIZE H
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12572759
• Report Number: 0001822565-2021-02865
• Device Sequence Number: 3373412
• Product Code: MBH
• UDI-Device Identifier: 00889024510623
• UDI-Public: (01)00889024510623(17)280831(10)64010550
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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: 42530008302
• Device Lot Number: 64010550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/11/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 111