MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 18X190MM SPL TPR DIST; PROSTHESIS, HIP

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/02/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-301114, arcos brch sz d hi 60mm, 508310.Unknown magnum head, unknown liner.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-06036.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [remains implanted].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient's right hip experienced greater trochanteric fracture approximately 2 months post implantation treated conservatively.No further information is available at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable as this device was not involved in the event.The initial report was submitted in error and should be voided.

• Brand Name: ARCOS 18X190MM 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: 7752300
• MDR Text Key: 116087787
• Report Number: 0001825034-2018-06037
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 11-300918
• Device Lot Number: 275100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/21/2018
• Supplement Dates FDA Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• 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
• Patient Age: 85 YR
• Patient Weight: 84