MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X25 SELF-TAP; PROSTHETIC, HIP

Model Number N/A

Device Problems Fracture (1260); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure 1 year and 2 months post implantation due to screw fracture and screw penetration.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).D10:00625006525 item name bone scr 6.5x25 selftap lot# j7167566; 00625006520 item name bone scr 6.5x20 self-tap lot # j7054522; 110010261 item name g7 osseoti multihole 46mm b lot # 7075146; 010000980 item name g7 freedom const e1 lnr 32mm b lot # 6918291 ; 802403203 item name zb 12/14 cocr frdm 32mm x +3 lot # 3001444.G2: foreign: japan.Multiple mdr reports were filed for this event, please see associated reports 0001822565 - 2023 - 03501.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, a supplemental medwatch will be submitted h3 other text : device location is unknown.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

Visual examination of the provided pictures identified the explanted shell and screws, with one screw fractured.No further evaluation can be made from the provided pictures.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.A definitive root cause cannot be identified.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 6.5X25 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: 18284771
• MDR Text Key: 329959492
• Report Number: 0001822565-2023-03502
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119819
• UDI-Public: (01)00889024119819(17)320305(10)J7211462
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K953337
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00625006525
• Device Lot Number: J7211462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose