MAUDE Adverse Event Report: . ALL-POLY PATELLA CEMENTED 29 MM DIAMETER; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 42512000413 lot number: 62470468 brand : persona cr ve articular surface, catalog number: 42-5320-067-01 lot number:63553382 brand : persona stemmed 5 degree tibia, catalog number: 42557000114 lot number:63575982 brand : persona str smooth stems, catalog number: 42502006601 lot number:62789215 brand : persona cr narrow femoral.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2018 -06608, 0001822565 -2018 -06609, 0001822565 -2018 -06610, 0001822565 -2018 -06611.Product has not been returned to zimmer biomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.

Event Description

It was reported that the patient underwent a total knee arthroplasty.Subsequently, the patient is suffering from pain post surgery.No revision occurred, implant remains in patient.No additional information on the reported event is unavailable.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.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.

• Brand Name: ALL-POLY PATELLA CEMENTED 29 MM DIAMETER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): .; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8117744
• MDR Text Key: 128860612
• Report Number: 0001822565-2018-06612
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• 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: 02/19/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 42540200029
• Device Lot Number: 63432254
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR