MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SHELL; PROTHESIS, HIPS

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

D10: 00625006530 bone scr 6.5x30 self-tap j7487162 multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02727 customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the acetabular screw went completely through the screw hole in the shell.A surgical delay was present as the surgeon had to pull the well-fixed acetabular component to retrieve the defective screw.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, h2, h3, h6 no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided for the shell.Complaint history review cannot be performed without product identification for the shell.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single fixation screw within the acetabulum as noted, which has passed through the screw aperture with no cup fixation from the screw.A definitive root cause cannot be determined.This complaint was confirmed based on the provided x-rays.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 additional event information to report at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified there is no damage to the threads.There is scuffing to the profile of the screw head.The lip of the screw head has material that is rolled, and the center hole has been stripped.No measurements were taken as the head of the screw has been damaged.The shell was not returned.Complaint history review cannot be performed without product identification for the shell.Root cause unchanged.This complaint was confirmed based on the provided x-rays confirming the reported event.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.

• Brand Name: UNKNOWN SHELL
• Type of Device: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): .; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17878487
• MDR Text Key: 325017819
• Report Number: 0001822565-2023-02730
• Device Sequence Number: 1
• Product Code: JDI
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNK SHELL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 11/09/2023; 04/16/2024
• Supplement Dates FDA Received: 11/13/2023; 04/17/2024
• 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
• Treatment: SEE H10 NARRATIVE