MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 67MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 03/06/2023

Event Type  Injury  

Event Description

 it was reported that initial total knee arthroplasty was performed.Postoperatively, approximately 2 months post procedure, the locking bar backed out.A revision is planned.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products:ve183722 vgd ve ps+ tib brg 63/67x12mm lot# 65268817, 183106 van ps open intl fem-rt 62.5 lot# j7235689.

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.   no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this/these item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified that the locking was backed out.Complaint is confirmed via x-ray review.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: BIOMET CC CRUCIATE TRAY 67MM
• 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: 16629542
• MDR Text Key: 312193755
• Report Number: 0001825034-2023-00665
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00887868558665
• UDI-Public: (01)00887868558665(17)320810(10)J7315545
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141232
• Device Lot Number: J7315545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• 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: Prefer Not To Disclose