MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMORAL DIST AUGMENT CEMENTED SIZE 11, 11+5MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	02/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, a morbidly obese patient began to experience an increase in pain.And reports, taking a 'couple tumbles' approximately 8 months post implantation.Patient presented to the er at this time.During this visit, the patient reports running out of norco, as it was being taken more than prescribed for the pain.A ct scan was performed and displayed no abnormal findings.And the patient was sent home with over-the-counter nsaids and topical analgesics.All implants remain in place.And the patient has continued within the study without further complication to the study knee.
Additional Manufacturer Narrative
(b)(4).Customer has indicated, that 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: 42504607002, persona femur cemented std right size 11, lot#: 64532701; 42545001012, persona femoral central cone size medium, lot# :64189936; 42556807005, persona femoral post augment cemented size 11, 11+5mm, lot# :64485584; 42560113520, persona stem ext straight splined uncemented 20mm dia 135mm l, lot#: 64635804; 42542007902, persona tibia fixed cemented right size g, lot#: 64334603; 42560613514, persona stem ext 6mm offset splined uncemented 14mm dia 135mm l, lot#: 64729231; 42545000513, persona tibial central cone size large, lot#: 64189641.42522601012, persona articular surface fxd brg (cps) right 12 mm lot#.
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; visual and dimensional evaluations could not be performed.A ct scan was performed and displayed no abnormal findings.No further analysis can be made.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.An adequate complaint history review cannot be performed as the complication, failure mode, and/or harm experienced by the user is unknown.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the event is for pain and multiple falls with unknown cause and is considered a serious injury as the illness or impairment required hospitalisation, medical intervention and/or surgical intervention.Discharge instructions: nsaids, otc topical analgesics, heat/ice.This complaint cannot be confirmed.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.

• Brand Name: PERSONA FEMORAL DIST AUGMENT CEMENTED SIZE 11, 11+5MM
• 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: 19119246
• Report Number: 0001822565-2024-01267
• Device Sequence Number: 7759923
• Product Code: JWH
• UDI-Device Identifier: 00889024556751
• UDI-Public: (01)00889024556751(17)300228(10)64664231
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 42556607005
• Device Lot Number: 64664231
• 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: 09/10/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2020
• 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; Hospitalization
• Patient Sex: Male
• Patient Weight: 171 KG