MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZB 12/14 COCR HEADD 28MM X +3.5; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 11/11/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer cat# 00-7850-013-00 lot 65299499 stem; zimmer cat# 00-7859-010-00 lot 65353398 stem centralizer.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2022 - 00249; 0002648920 - 2022 - 00251.

Event Description

It was reported the patient underwent a left initial hemiarthroplasty that was subsequently revised approximately 3 (three) months later due to dislocations from recurrent falls.The shell, liner, and head were exchanged without complications.Attempts have been made and the additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- head.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: through follow up visits, the patient reported suffering from recurrent falls with repeated dislocations and instability.It was decided to convert to total hip and the patient was revised.The shell, head, and liner were replaced, no complications noted.Review of the device history records identified no deviations or anomalies during manufacturing.It was noted the patient suffered from recurrent falls leading to dislocations.As the reason for the falls are 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.

Event Description

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

• Brand Name: ZB 12/14 COCR HEADD 28MM X +3.5
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15973537
• MDR Text Key: 305413651
• Report Number: 0002648920-2022-00250
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024498792
• UDI-Public: (01)00889024498792(17)320514(10)65379287
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: 802202803
• Device Lot Number: 65379287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 68 KG