MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM MOD HEAD COCR +9MM NECK; PROSTHETIC, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Pain (1994)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 010000927, item name: g7 hi-wall e1 liner 32mm e, lot#: 7095016.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports 0001825034-2023-02916.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

It was reported that the patient underwent a revision procedure 7 months post implantation due to pain, neuropathy and leg lengthening.There is no additional information available at the time of this report.

Manufacturer Narrative

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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty with long femoral neck and possible erosive change versus subchondral cystic formation along the superior and lateral acetabular.A definitive root cause cannot be determined for the pain and leg lengthening.No problem was found with the devices in relation to the neuropathy after review by a hcp.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.

Event Description

There is no update to the prior event description provided.

• Brand Name: 32MM MOD HEAD COCR +9MM NECK
• 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: 18285966
• MDR Text Key: 329996221
• Report Number: 0001825034-2023-02917
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00880304256682
• UDI-Public: (01)00880304256682(17)280228(10)372090
• 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: 03/14/2024

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 163672
• Device Lot Number: 372090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• 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: PLEASE SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose