MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X30 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem Insufficient Information (4580)

Event Date 12/27/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial hip procedure on an unknown date.Subsequently, the patient was revised as the implanted screw appeared to have gone through the screw hole of the cup.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2024 - 00168.D10: cat# 110010245 lot# 66005221 g7 osseoti 4 hole shell 54mm f.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient underwent an initial hip procedure.Subsequently, the patient was revised the same day, as the post op x-ray showed the implanted screw appeared to have gone through the screw hole of the cup.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

No further information at the time of this report.

Event Description

No further information 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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: anatomic alignment of the right hip arthroplasty.Passage of an acetabular fixation screw through the screw aperture as noted.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.

• Brand Name: BONE SCR 6.5X30 SELF-TAP
• Type of Device: PROSTHESIS, HIP
• 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: 18545378
• MDR Text Key: 333271017
• Report Number: 0001822565-2024-00169
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119826
• UDI-Public: (01)00889024119826(17)330228(10)J7464080
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• 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,Followup
• Report Date: 04/23/2024

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: 00625006530
• Device Lot Number: J7464080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 01/19/2024; 03/29/2024; 04/22/2024
• Supplement Dates FDA Received: 01/26/2024; 03/29/2024; 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male