MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BROACH; HIP INSTRUMENT

Model Number N/A

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

Patient Problem Bone Fracture(s) (1870)

Event Date 02/11/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00408801206, versys epoch stem, 61498367.00620005022, shell, 61439107.00630505032, liner, 61620350.00801803203, head, 61693390.Reported event was confirmed by review of medical records noting a small crack occurred on the calcar and was treated with a fully porous coated implant.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03143.

Event Description

It was reported that during an initial right total hip arthroplasty the patient experienced a small calcar fracture and treated with fully porous coated implant.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN BROACH
• Type of Device: HIP INSTRUMENT
• 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: 10487028
• MDR Text Key: 205468656
• Report Number: 0001822565-2020-03144
• Device Sequence Number: 1
• Product Code: HTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 58