MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA STEM EXT 3MM OFFSET SPLD UNCEMENTED 12MM 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); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent right knee a two stage revision for infection.Subsequently, approximately 7 months later the patient began to have intermittent pain and swelling and 2 years five months reported an increase in pain and was prescribed physical therapy.All implants remain in place.
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 ------------------------------------------- 42504606212 persona femur cemented plus right size 7+ lot# 64767893 42560113516 persona stem ext straight spld uncemented 16mm dia +135mm l lot# 64783575 42545001011 persona femoral central cone size small lot# 64643091 42556606205 persona femoral distal augment cemented size 7, 7+ 5mm lot# 64859431 42542006702 persona tibia fixed cemented right size d lot# 64565801 42522600516 persona articular surface fixed bearing (cps) right 16mm lot# 64647943 42545000512 persona tibial central cone size medium lot# 64680480 00587806532 nexgen complete knee solution trabecular metal std patella lot# 64227939.
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.Updated: b4, b5, g3, g6, h1, h2, h3, h4, h6, h10, h11.H6-component code- suggested code: mechanical (g04) stem.No products were returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the devices 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.Office notes were provided and report pain, swelling and trouble ambulating.The patient also reported fall on ice.X-rays taken during visit state no periprosthetic fracture and implants are well positioned.X-rays reviewed over two months during which shows a stable appearance of revision components.The patient reports increasing right knee pain resulting in physical therapy.Complaint is not 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 STEM EXT 3MM OFFSET SPLD UNCEMENTED 12MM 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: 19139741
• Report Number: 0001822565-2024-01321
• Device Sequence Number: 20943724
• Product Code: JWH
• UDI-Device Identifier: 00887868250026
• UDI-Public: (01)00887868250026(17)300131(10)64675872
• 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): 09/10/2024

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: 42560313512
• Device Lot Number: 64675872
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White