MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN BI-METRIC RASP; PROTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

Patient's dob, month and day - ni.The following sections could not be completed with the information provided: implant date: n/a.Explant date: n/a.Expiration date: ni.Establishment name: ni.Manufacture date: ni.

Event Description

It was reported that the patient's femur was fractured during initial implantation of a total hip.A cemented stem and cerclage wires were utilized to complete the procedure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were corrected.(b)(6).

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Reported event was unable to be confirmed as part number/lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported that the patient's femur was fractured during initial implantation of a total hip.A cemented stem and cerclage wires were utilized to complete the procedure.Operative report noted a delay for an unspecified amount of time.

• Brand Name: UNKNOWN BI-METRIC RASP
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6185686
• MDR Text Key: 62745754
• Report Number: 0001825034-2016-05252
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/22/2016,06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2016
• Date Manufacturer Received: 06/09/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 92