MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X20 SELF-TAP; PROSTHETIC, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Malposition of Device (2616)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

It was reported that when inserting screws into a tm modular cup, one of the screws a size 20mm went completely through the screw hole and through the other side of the bone.The screw was left in the patient.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).Report source: foreign: new zealand.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00575.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.Device location is unknown.

Event Description

There is no additional information available 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 related to the reported event.Medical records were not provided.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 6.5X20 SELF-TAP
• Type of Device: PROSTHETIC, 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: 16486341
• MDR Text Key: 310713289
• Report Number: 0001822565-2023-00574
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024119802
• UDI-Public: (01)00889024119802(17)320624(10)J7288428
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K934765
• 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
• Report Date: 04/25/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006520
• Device Lot Number: J7288428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN TM CUP
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 75 KG