MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA NATURAL TIBIA CEMENTED 5 DEG STEMMED LEFT SZ G; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint effusion (4849)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products ------------------------------------------- 42512100914 persona art surface mc left 14mm lot# 63841871 42502606601 persona femoral cemented cr std left sz 9 lot# 63681226 42540000041 persona all poly patella cemented 41mm dia 10mm lot# 63716234 00111214001 palacos r 1x40 single lot# 86934602 00111214001 palacos r 1x40 single lot# 86934602.
Event or Problem Description
It was reported a patient had an initial left total knee arthroplasty followed by a i&d with poly exchange about one month post implantation for infection.Subsequently, the patient began to experience persistent pain and swelling and upon assessment was diagnosed with mechanical loosening.Two years, five months after the i&d revision the patient underwent a revision due to aseptic failure.During the revision, encountered synovitis, pitting to the poly from third body wear, and defects noted on the femoral and tibial components.All components were revised without complication.
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.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this/these items and the reported part and lot combinations.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 1st clinic visit- swelling, acute pain.¿ 2nd visit- moderate/continual pain, increased pain and large effusions over last several months.Aspiration- 120 cc blood-tinged synovial fluid ¿ sent for culture.Ordered bone scan & x-rays: no significant findings; well fixed without obvious loosening, subsidence, fracture.¿ 3rd clinic visit- significant pain for 4 months ¿ worsening.Aspiration from last visit showed 2300 white cells, 30% pmn and negative culture.Bone scan dramatically positive on the femur and patella.Assessment: mechanical loosening of internal prosthetic joint revision procedure- revision for persistent pain with aseptic failure, instability.Dramatic synovial reaction, very dense synovitis.Polyethylene had pitting damage throughout, appearing to be from third body wear.'no gross failure but pitting throughout both surfaces'.'she had a contained defect on the medial femoral condyle that was fairly dramatic, but structural stability of the condyle was intact as far as the medial collateral ligament structures are concerned'.'upon removing the femoral component, only cement on the posterior condyles.Tibia was well fixed, after removal, showed a contained defect centrally but an excellent permanent rim.No intra-operative events/complications'.Aspirin for dvt prophylaxis.Xrays: 4 pre-operative images assessed and not submitted to mmi as they are prior to the initial surgery and would not benefit the investigation).This complaint cannot be confirmed.No corrective actions, preventive actions, or field actions resulted after investigation of this event.A definitive root cause cannot be determined.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 TIBIA CEMENTED 5 DEG STEMMED LEFT SZ G
• 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: 19159457
• Report Number: 0001822565-2024-01357
• Device Sequence Number: 7862351
• Product Code: JWH
• UDI-Device Identifier: 00889024471092
• UDI-Public: (01)00889024471092(17)270731(10)63717624
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted 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): 09/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532007901
• Device Lot Number: 63717624
• 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: 09/13/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2017
• 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; Hospitalization
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White