MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 10 PS PLUS ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 05/09/2022

Event Type  Injury  

Event Description

It was reported that a patient was revised approximately two years and three months post implantation due to size of implant, pain, instability, ligament laxity, implant wear, dislocation, difficulty walking without a cane or walker and difficulty doing any daily activities.During the revision the femoral component was noted to be oversized with significant anterior and posterior overhang.There was also significant ligament laxity with flexion and extension.Although medial wear was noted on the patellar component, this remained in place with a retinaculum repair performed to improve tracking.All other components were revised without complication.Attempts to obtain additional information have been made; however, no more information is available.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2022-01702, 0001825034-2022-01704, 0001825034-2022-00713-2.Medical product unknown vanguard 65 femoral, unknown 80mm stem, unknown 83 tibial tray.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Primary operative notes state there were no intraoperative complications.Revision operative notes state that patient was revised due to pain and ligament instability.Gross laxity in extension and flexion.Patella showed medial wear consistent with subluxation or dislocation.Patellar button intact and decision was made to retain, lateral retinacular release performed to improve patellar tracking.Notes also state that implants appear oversized and femoral component shows significant anterior and posterior overhang.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.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.

• Brand Name: UNKNOWN 10 PS PLUS ARTICULAR SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15094965
• MDR Text Key: 296501468
• Report Number: 0001825034-2022-01703
• Device Sequence Number: 1
• Product Code: HSA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White