MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHETIC, HIP

Model Number N/A

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 10/19/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure due to implant wear and instability.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02651; 0001825034 - 2023 - 02653; 0001825034 - 2023 - 02654.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

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).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.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Medical radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right tha with shallow acetabular cup and undersized femoral head and short femoral neck.Mild radiolucency along the femoral diaphysis with cortical thickening could indicate loosening.The complaint cannot be confirmed by the provided radiographs.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: UNKNOWN LINER
• Type of Device: PROSTHETIC, 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: 18133314
• MDR Text Key: 328073750
• Report Number: 0001825034-2023-02652
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NI
• 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: 02/23/2024

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: Lay User/Patient
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/23/2024
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HEAD, UNKNOWN STEM, UNKNOWN CUP.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose