MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION VIVACIT-E FIXED BEARING ARTICULAR SURFACE RIGHT 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Post Operative Wound Infection (2446)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - unknown persona revision knee femoral component catalog #: ni lot #: ni, unknown persona revision knee tibial component catalog #: ni lot #: ni.The complainant has not yet indicated whether the product will be returned to zimmer biomet for investigation.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 an irrigation and debridement of the knee and revision of the articular surface to address a seroma seventeen (17) days following knee arthroplasty.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that the patient underwent an irrigation and debridement of the knee and revision of the articular surface to address a seroma seventeen (17) days following knee arthroplasty.The patient was additionally treated with 6 weeks of intravenous antibiotics.Attempts have been made, however, no additional information is available.
Event or Problem Description
It was reported that the patient underwent an irrigation and debridement of the knee and revision of the articular surface to address a seroma seventeen (17) days following knee arthroplasty.The patient was additionally treated with 6 weeks of intravenous antibiotics.Initial operative notes noted no intraoperative complications related to the patient's post-operative infection.Revision operative notes noted there was draining from the wound post-operatively.A small subcutaneous hematoma and a large intra-articular hematoma were identified, however did not appear infected.The hematomas were drained, irrigation and debridement was performed and the articular surface was exchanged.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: concomitant devices - persona revision cemented tibial augment half block size cd 10mm catalog#: 42555803410, lot#: 64567521, persona revision cemented tibial augment half block size cd 10mm catalog#: 42555803210, lot#: 64508897, persona revision straight splined stem extension 10mm x 135mm catalog#: 42560113510, lot#: 64707569, persona revision cemented standard femoral component size 5 right catalog#: 42504605802, lot#: 64780233, persona revision cemented tibial component size c right catalog#: 42542006402, lot#: 64334628, persona revision straight splined stem extension 11mm x 135mm catalog#: 42560113511, lot#: 64769674.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure.The development of a postoperative hematoma after a procedure can be correlated with the surgical procedure and perioperative anticoagulation therapy to prevent dvt (prophylaxis).Patients may be at increased risk for developing hematomas if they have received fresh-frozen plasma, vitamin k, or hormonal therapy as well.Most hematomas resolve on their own, without surgical intervention, while some others do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.Hematoma formation also places the patient at increased risk for infection.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.The root cause is attributed to non-device related factors.As it was identified that this event is not related to zimmer biomet devices, zimmer biomet no longer considers this event reportable.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 REVISION VIVACIT-E FIXED BEARING ARTICULAR SURFACE RIGHT 10MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13568157
• Report Number: 0001822565-2022-00471
• Device Sequence Number: 20295693
• Product Code: JWH
• UDI-Device Identifier: 00889024555037
• UDI-Public: (01)00889024555037(17)240531(10)64338842
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 04/08/2022

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 Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42522800410
• Device Lot Number: 64338842
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 02/23/2022; 03/22/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 03/21/2022; 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2019
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White