MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM MOD HD CERAMIC -5MM NK; PROSTHESIS, HIP

Catalog Number 163130

Device Problem Unstable (1667)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2023

Event Type  Injury  

Event Description

It was reported a patient underwent a hip revision approximately ten years post implantation due to liner wear and instability.During the procedure, it was noted that the femoral component was well fixed, the trunnion was in great condition, and the cup was well fixed and difficult to remove.The shell, liner and head were removed and replaced.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02766, 0001825034-2023-02768.G2: australia.H10: cat#: 11-104252 / mlry-hd hexlc acet shl 52mm / lot #: 856850.Cat #: 104346 / acet lnr 10 deg 28mm id sz b / lot #: 816590.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.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined to be not reportable as this product did not cause or contribute to the event.The initial report should be voided.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable as this product did not cause or contribute to the event.The initial report should be voided.

• Brand Name: 28MM MOD HD CERAMIC -5MM NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18229022
• MDR Text Key: 329262852
• Report Number: 0001825034-2023-02767
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K942479
• 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: 04/16/2024

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 Catalogue Number: 163130
• Device Lot Number: 25841T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/16/2024
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 54 KG