MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL TIBIAL CEMENTED; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of birth: (b)(6).(b)(4).Concomitant medical products: persona partial femur cemented catalog # 42558000502 lot # 63521193.Persona partial articular surface catalog # 42528200508 lot # 63649733.Report source: (b)(6).Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2019-00505, 0001822565-2019-00510.

Event Description

It was reported that the patient underwent a right knee arthroplasty.Subsequently, the patient was experiencing pain during post-op follow up.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Review of the device history record (dhr) found three scrapped parts, which could likely be related to the reported event.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Review of the device history record (dhr) found three scrapped parts in which the non-conformance is unrelated to the reported event.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable under this mfr number.This event will be reported under correct manufacturing site mdr 0001825034-2021-01582.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable under this mfr number.This event will be reported under correct manufacturing site mdr 0001825034-2021-01582.

• Brand Name: PERSONA PARTIAL TIBIAL CEMENTED
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8335104
• MDR Text Key: 136007136
• Report Number: 0001822565-2019-00509
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000502
• Device Lot Number: 63643095
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 119