MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL POSTERIOR AUGMENT CEMENTED SIZE 9, 9+ 5 MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/10/2023

Event Type  Injury  

Event Description

It was reported screw head snapped off on posterior femoral augment.Screw theads were contained within the femoral implant.No pieces fell into the patient.Both femoral augments are reported as it is not clear which augment the screw was packaged with.

Manufacturer Narrative

(b)(4).G2: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown with which implant the suspect screw was packaged.Therefore both items/lots/udis are listed below: item 42556806605 lot# 65263710.(b)(4).Item 42556806605 lot# 65793236.Udi:(b)(4).

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.Item 42556806605 lot# 65263710.Expiration date: feb 28, 2032.Manufacturing date: mar 7, 2022.Item 42556806605 lot# 65793236.Expiration date: mar 5, 2033.Manufacturing date: mar 13, 2023.  no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted (the screw included with the augment is compatible with the augment it is packaged with).Medical records were not provided.This complaint could not be confirmed by the information provided.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: FEMORAL POSTERIOR AUGMENT CEMENTED SIZE 9, 9+ 5 MM
• 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: 17437962
• MDR Text Key: 320174495
• Report Number: 0001822565-2023-02043
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K181947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Sex: Prefer Not To Disclose