MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ARCOS PROXIMAL BODY; 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.

Manufacturer Narrative

Proposed component code mechanical (g04) - stem.No product was returned; 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/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues, revision of arcos proximal body head and dm bearing revision.Neck of the arcos proximal body impinges on the cup causing metallosis.Right tha with long stem femoral component.Oversized acetabular cup with short femoral neck causing impingement on frog leg views.Screw fragment proximal femoral diaphysis.A definitive root cause cannot be determined.The event is confirmed via medical records 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.

Event Description

No additional event information to report at this time.

• Brand Name: UNKNOWN ARCOS PROXIMAL BODY
• Type of Device: PROTHESIS, HIPS
• 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: 18162562
• MDR Text Key: 328429973
• Report Number: 0001825034-2023-02707
• Device Sequence Number: 1
• Product Code: KWT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

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 ARCOS PROX BODY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2023
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female