MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 17X150MM SPL TPR DIST; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)

Event Date 11/26/2018

Event Type  Injury  

Event Description

It was reported that during a revision procedure, the surgeon noted the right greater trochanter fracture was further fractured during the placement of the stem.The stem was removed and a longer stem was placed along with cables to reduce fracture site.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: ref 00-6250-065-25 lot 62869681 bone screw 6.5x25 selftap; ref 00-8757-052-01 lot 62831028 continuum cluster-hole shell, 52; ref 98-0001-005-80 lot por st/tm cup/lg vit e.The device will not be returned for analysis, due to the device being discarded; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Upon reassessment of the reported event, it was determined this is an ongoing event related to the initial devices that were reported in 0001822565-2021-01182 and 0001822565-2021-03697.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined this is an ongoing event related to the initial devices that were reported in 0001822565-2021-01182 and 0001822565-2021-03697.The initial report was forwarded in error and should be voided.

• Brand Name: ARCOS 17X150MM SPL TPR DIST
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13191453
• MDR Text Key: 283400118
• Report Number: 0001825034-2022-00064
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-300817
• Device Lot Number: 538740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2022
• 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): Other
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White