MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERSONA FEMORAL COMPONENT; PROSTHESIS, KNEE

Catalog Number KNE-PERSONA-FEMORALS-UNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Rash (2033); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

It was reported that implant date occurred between (b)(6) 2020 and (b)(6) 2020.Medical product: unknown persona bearing catalog#: ni, lot#: ni, unknown persona tibial tray catalog#: ni, lot#: ni, stryker bone cement catalog#: ni, lot#: ni.(b)(4).Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-02442, 0001822565-2021-02443.

Event Description

It was reported that patient underwent a total knee arthroplasty at an unknown date.Between 8 and 20 months post implantation, patient began experiencing pain, swelling and localized rash.Products remain implanted.Attempts have been made and no further information was provided.

Event Description

No further event information available at time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; h2; h3; h6; h10.A visual inspection of the item could not be performed as no product was returned nor were pictures provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : see h10 narrative.

• Brand Name: UNKNOWN PERSONA FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12392600
• MDR Text Key: 268973728
• Report Number: 0001822565-2021-02444
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: KNE-PERSONA-FEMORALS-UNK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other