MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN TIB POR 2 PEG SZ D R; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 42522200411 - articular surface ¿ 62284770, 42502206002 - femur trabecular metal ¿ 62614803, 00587806535 - trabecular metal standard primary patella - 62659611.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was retained by the hospital.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 - 2019 - 02998.

Event Description

It was reported that the patient underwent revision surgery approximately 5 years post implantation due to pain.It was noted that only the tibial component and bearing were revised.

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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the right knee arthroplasty components are anatomically aligned.There is no dislocation or fracture.There is a small amount of radiolucency along the margins of the tibial component and also the patellar component without radiographic evidence of frank component loosening.There is slight asymmetric narrowing of the medial tibiofemoral space when compared to the lateral on the ap view which may reflect liner wear.Bone quality appears mildly osteopenic.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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.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.

• Brand Name: PSN TIB POR 2 PEG SZ D R
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8801048
• MDR Text Key: 151401135
• Report Number: 0001822565-2019-02997
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 42530006702
• Device Lot Number: 62438474
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR