MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM DIA COCR MOD HD +3MM NK; PROSTHETIC, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Joint Dislocation (2374)

Event Date 09/11/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure 17 days post implantation due to dislocation post periprosthetic fracture.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).D10: 010000835.Item name g7 neutral e1 liner 28mm a.Lot # 6831926.51-116110.Item name tprlc 133 mp type1 bm so 11.0.Lot: 7257654.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02264.0001825034 - 2023 - 02262.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h6 component code: mechanical (g04) - head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dislocation was confirmed based on evaluation of the provided medical records.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is a right hip arthroplasty.The acetabular implant appears possibly malrotated and there is subluxation/dislocation.No fracture is identified.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.

Event Description

There is no update to the prior event description provided.

• Brand Name: 28MM DIA COCR MOD HD +3MM NK
• 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: 17867430
• MDR Text Key: 324867872
• Report Number: 0001825034-2023-02263
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00887868308284
• UDI-Public: (01)00887868308284(17)330102(10)J7421719
• 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: 11/16/2023

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
• Device Catalogue Number: 163663
• Device Lot Number: J7421719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2023
• 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: Female
• Patient Weight: 112 KG