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

Catalog Number 00625006525

Device Problem Unstable (1667)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00778 0002648920-2024-00080 0002648920-2024-00081 d10: cat #: 110010264 / g7 osseoti multihole 52mm e / lot #: 66347196 cat #: 00625006550 / trilogy bone scr 6.5x50 / lost #: 63033489 cat #: 00625006550 / trilogy bone scr 6.5x50 / lot #: 63849814 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that a patient is being scheduled for a left hip revision approximately three months post implantation due to inadequate fixation of the cup.To date, no procedure has occurred.Attempts have been made and no further information is available.

• Brand Name: BONE SCR 6.5X25 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: 18967470
• MDR Text Key: 338468061
• Report Number: 0001822565-2024-00991
• Device Sequence Number: 1
• Product Code: LPH
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00625006525
• Device Lot Number: J7012414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other