MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA STEM EXT 6MM OFFSET SPLINED UNCEMENTED 20MM DIA 135MM L; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Joint Contracture (4528)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had a total knee revision 4 years post implantation due to infection.An additional revision of the patellar component took place approximately 18 months post procedure due to aseptic loosening.Subsequently, the patient reported an onset of anterior knee pain that began 8 months after the patella revision.No additional information regarding intervention or outcome was provided.
Additional Manufacturer Narrative
(b)(4).The product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 42504606612 persona femur cemented plus right size 9+ lot#: 64890192.42542007502 persona tibia fixed cemented right size f lot#: 65016898.42522800712 persona articular surface fxd brg constrained condylar knee rt 12mm lot#: 64751693.42560113515 persona stem ext straight splined uncemented 15mm dia +135mm l lot#: 64997634.42545000512 persona tibial central cone size medium lot#: 64815928.42555805405 persona tibial augment cemented half block rt medial size ef 5mm lot#: 64707514.Unk patella lot#: unk.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1, a4, b4, b5, b7, e1, e2, e3, g3, g6, h1, h2, h6, h10, h11.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 42504606612 persona femur cemented plus right size 9+ lot# 64890192.42542007502 persona tibia fixed cemented right size f lot# 65016898.42522800712 persona articular surface fxd brg constrained condylar knee rt 12mm lot# 64751693.42560113515 persona stem ext straight splined uncemented 15mm dia +135mm l lot# 64997634.42545000512 persona tibial central cone size medium lot# 64815928.42555805405 persona tibial augment cemented half block rt medial size ef 5mm lot# 64707514.00597206535 nexgen all poly patella 35mm- cemented lot# 65656368.
Event or Problem Description
It was reported a patient had a total knee revision 4 years post implantation due to infection.An additional revision of the patellar component took place approximately 18 months post procedure due to aseptic loosening.Subsequently, the patient reported an onset of anterior knee pain that began 8 months after the patella revision.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h10, h11.H6-component code- suggested code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: office notes 1st follow up: anterior knee pain, 'has flat back syndrome and walks with his knees in a flexed position'; office notes 2nd follow up: chronic knee pain after replacement of right knee joint.Trouble with ambulation and rom complaint is confirmed with the provided medical records.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 STEM EXT 6MM OFFSET SPLINED UNCEMENTED 20MM DIA 135MM L
• 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: 19119363
• Report Number: 0001822565-2024-01276
• Device Sequence Number: 8248330
• Product Code: JWH
• UDI-Device Identifier: 00887868250330
• UDI-Public: (01)00887868250330(17)300630(10)64777480
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42560613520
• Device Lot Number: 64777480
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 06/14/2024; 09/20/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 07/02/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White