MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 38 MM DIAMETER; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Unspecified Infection (1930)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: (b)(6)2019 42500607001 - femur cemented posterior stabilized ¿ 64105209, 42530007901 - natural tibia trabecular metal ¿ 64140981, 42511401014 - articular surface fixed bearing ¿ 64090617.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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: 3007963827 - 2019 - 00342, 0001822565 - 2019 - 05155, 3007963827 - 2019 - 00343.

Event Description

It was reported that the patient underwent knee revision approximately 6 weeks post implantation due to infection.All components were removed and antibiotic spacers were implanted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no intra-operative complications noted during the primary surgery.The patient started experiencing infection within a month of primary ops.During the revision surgery, the surgeon noted brown fluid in the knee joint and tibia was loose.All implants were replaced with cement spacers.Per package insert for the persona personalized knee system: infection and loosening are known adverse effects of this procedure.However, a definitive root cause cannot be determined.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.

Event Description

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

• Brand Name: ALL POLY PATELLA CEMENTED 38 MM DIAMETER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 9418545
• MDR Text Key: 169512609
• Report Number: 0002648920-2019-00883
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• 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: 03/02/2020

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 Model Number: N/A
• Device Catalogue Number: 42540000038
• Device Lot Number: 64342511
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 02/28/2020
• Supplement Dates FDA Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 99