MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL TRAY FIXED BEARING SIZE 4; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Swelling (2091); Tissue Damage (2104); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: therapy date: unknown.90597003012, articular surface regular constraint, 62469669.00575201402, cruciate retaining cr-flex gender, 62160513.00587806535, nexgenâ® complete knee solution, 62536488.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: 0001822565 - 2019 - 03778, 0001822565 - 2019 - 03779.

Event Description

It was reported that the patient began experiencing pain approximately 4 years post implantation.Subsequently, the patient underwent arthroscopy procedure where the surgeon cleaned out the knee and found minor quad tear.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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

It was reported that the patient underwent initial right total knee arthroplasty.Subsequently, the patient reported irritation around the joint and was treated with increased pain medication and knee brace for patellar tendinitis.The patient then underwent and arthroscopy due to ongoing pain and swelling approximately 3.5 years post implantation.During the arthroscopy, significant scar tissue was debrided from the joint and a quadriceps tear was repaired.No product was exchanged.

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 no intraoperative complications during the initial surgery.The patient underwent arthroscopy due to pain and swelling approximately 3.5 years post implantation.Significant fibrosis was noted during the arthroscopy.The complaint was confirmed by the medical records review.Per the nexgen cr, ps, cra, lps and lcck package insert, pain and swelling are known potential adverse effects of this procedure.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: TIBIAL TRAY FIXED BEARING SIZE 4
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8956827
• MDR Text Key: 156388892
• Report Number: 0001822565-2019-03781
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K072160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2020

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 Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 00595403702
• Device Lot Number: 62569192
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 12/05/2019; 02/10/2020
• Supplement Dates FDA Received: 12/30/2019; 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 77