MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK); PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fall (1848); Unspecified Infection (1930)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical device: all poly patella standard size 35 mm diameter 9.0 mm thickness cemented catalog # 00597206535 lot # 64774929.Femur cemented standard right size 5 catalog # 42504605802 lot # 64636329.Stem extension straight splined uncemented 13 mm diameter +135 mm length catalog # 42560113513 lot # 64660921.Tibia fixed non-porous right size c stem extension use required catalog # 42542006402 lot # 64394507.Stem extension straight splined uncemented 10 mm diameter +135mm length catalog # 42560113510 lot # 64580997.All poly patella standard size 35 mm diameter 9.0 mm thickness cemented catalog # 00597206535 lot # 64774931 femoral distal augment size 5, 5+ 5 mm thickness catalog # 42556605805 lot # 64610692.Femoral distal augment size 5, 5+ 10 mm thickness catalog # 42556605810 lot # 64610726.Tibial central cone size x-small catalog # 42545000510 lot # 64788568.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient experienced a delay in wound healing and possible infection.The patient was also noted to have fallen.The surgeon performed a wash out and debridement procedure.The articular surface prosthesis was replaced.During the procedure, wear was noticed on explanted device.Attempt for further information has been made, but no further information has been provided.
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: b4, b5, d4, g4, g7, h1, h2, h3, h6, h9, h10.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of being implanted.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The root cause for the infection and the wound complication is not device related.The root cause for the reported issue could not be determined for wear of implant.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 ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK)
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11092091
• Report Number: 0001822565-2020-04184
• Device Sequence Number: 16811046
• Product Code: JWH
• UDI-Device Identifier: 00889024555044
• UDI-Public: (01)00889024555044
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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 Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42522800412
• Device Lot Number: 64372511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 Age: 62 YR