MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM CEMENTLESS COLLARLESS HIGH OFFSET 12/14 TAPER SIZE 6; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Necrosis (1971)

Event Date 04/04/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: cat#00-8755-052-02 shell lot#3097158; cat#00-8775-010-36 liner lot#3087512; cat#00-8775-036-02 head lot#3095862.Source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent initial hip arthroplasty.Subsequently the patient experienced necrosis and loss of activity approximately one year post implantation.Review of ct scan shows possible implant fracture.No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1; a2; a3; a4; b7; d4; h4.

Event Description

No further event information available at the time of this report.

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.Proposed component code: mechanical (g04)- stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.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

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number.(b)(4) zimmer.

Manufacturer Narrative

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number.(b)(4) zimmer.

• Brand Name: FEMORAL STEM CEMENTLESS COLLARLESS HIGH OFFSET 12/14 TAPER SIZE 6
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14141006
• MDR Text Key: 289500786
• Report Number: 0001825034-2022-00922
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024508798
• UDI-Public: (01)00889024508798(17)260331(10)3066887
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K182048
• 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,Followup,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• 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: 574102060
• Device Lot Number: 3066887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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 Age: 40 YR
• Patient Sex: Male
• Patient Weight: 105 KG