MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN G7 CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item # unknown unknown g7 liner lot# unknown, item # unknown unknown screw lot# unknown, unknown femoral head, unknown femoral stem.Reported event was confirmed by review of xrays which displayed liner asymmetrically seen medially.No evidence of abnormal radiolucency or loosening.The femoral head is laterally positioned within the acetabular shell possibly secondary to malfunction of the inner liner and osseous penetration of an acetabular fixation screw.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr's associated with this report: 0001825034 - 2018 - 03813 ; 0001825034 - 2018 - 03811.

Event Description

It was reported that patient underwent total hip arthroplasty; subsequently, the liner disassociated from the cup.No revision had taken place at time of reporting.Attempts were made to obtain further information; however, none was available.

• Brand Name: UNKNOWN G7 CUP
• 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: 7574902
• MDR Text Key: 110321618
• Report Number: 0001825034-2018-03812
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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?: No
• Date Manufacturer Received: 05/16/2018
• 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): Other