MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP; PROTHESIS, HIPS

Model Number N/A

Device Problems Corroded (1131); Unintended Movement (3026)

Patient Problem Metal Related Pathology (4530)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: foreign: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient with hip dysplasia had a right total hip arthroplasty.Subsequently, the patient underwent a revision surgery ten years post implantation, due to the neck of the arcos proximal body was impinging on the cup, causing metallosis.No additional information has been provided.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.D10: unknown screw unknown.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.Subsequently, a revision occurred due to the neck of the arcos body impinging on the cup causing metallosis.Records were not provided for the revision.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 1.Right tha with long stem femoral component.Oversized acetabular cup with short femoral neck causing impingement on frog leg views.2.Screw fragment proximal femoral diaphysis.A definitive root cause cannot be determined.This complaint was confirmed based on the provided x-rays.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN CUP
• Type of Device: PROTHESIS, HIPS
• 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: 18162637
• MDR Text Key: 328430469
• Report Number: 0001822565-2023-03275
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• 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: UNKNOWN CUP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female