MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 DM PROV LINER 44MM F; INSTRUMENT, HIP

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the wrong ean number was printed on label.No patient involvement.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Inspection of the pictures of the complaint product determined that the incorrect gtin number is printed on the label as reported.Review of the device history record determined that the incorrect gtin number is printed on the label.No other deviations identified.Review of the complaint history determined that no further action is required as no were trends identified.The root cause of the reported issue is attributed to operator error prior to established procedures or training being implemented.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the wrong gtin number (global trade item number) was printed on the label.No patient involvement.No adverse events have been reported as a result of the malfunction.

• Brand Name: G7 DM PROV LINER 44MM F
• Type of Device: INSTRUMENT, 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: 6370928
• MDR Text Key: 68768779
• Report Number: 0001825034-2017-01301
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK150522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110024732
• Device Lot Number: 693840
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1