MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZUK TIBIAL TRAY; PROSTHESIS, KNEE

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: literature.Plancher, k.D., brite, j.E., briggs, k.K., & petterson, s.C.(2022).Pre-arthritic/kinematic alignment in fixed-bearing medial unicompartmental knee arthroplasty results in return to activity at mean 10-year follow-up.The journal of bone and joint surgery.American volume, 104(12), 1081¿1089.Https://doi.Org/10.2106/jbjs.21.00801.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03454, 0001822565-2022-03455.

Event Description

A journal article was retrieved from the journal of bone and joint surgery (2022) that reported a retrospective study from the united states for surgeries performed by dr.Kevin p.Plancher between 2000-2015.The purpose of the study was to determine if pre-arthritic/kinematic alignment of knees would result in sustained long-term restoration of function, without conversion to total knee arthroplasty (tka), following non-robotically assisted, fixed bearing medial unicompartmental knee arthroplasty (uka).The study reviewed 150 medial ukas using the fixed-bearing uka (zimmer unicompartmental high flex knee system [zuk].A total of 127 knees (85%) were pre-arthritic/kinematically aligned, and 23 knees (15%) were to be non-pre-arthritic/kinematically aligned.The study population had a mean age of 65 +/- 10 years at time of surgery with 76 females and 74 males.Follow-up was conducted via retrospective radiograph review to obtain alignment measures and patient reported outcomes with a mean length of follow-up for 10 years (range, 4 to 20 years).The study reported one patient (patient 3, table 2) underwent conversion from an initial medial unicompartmental knee arthroplasty to a total knee 2 years postop due to technical errors.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.As information concerning the technical error 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 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: UNKNOWN ZUK TIBIAL TRAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15961922
• MDR Text Key: 305327466
• Report Number: 0001822565-2022-03453
• Device Sequence Number: 1
• Product Code: HSX
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2022
• 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 Age: 68 YR
• Patient Sex: Female