MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FREEDOM CONST E1 LNR 36MM G; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 110010284, g7 freedom const e1 10deg liner 36g, 3532618.11-107020, freedom constr hd 36mm t1 +6mm, 769940.11-302101, arcos troch claw large 100mm, 696090.00625006525, bone scr 6.5x25 self-tap, 63585022.11-302136, arcos lateral troch bolt 36mm, 489960.00625006525, bone scr 6.5x25 self-tap, 63341510.00625006520, bone scr 6.5x20 self-tap, 63572909.00625006515, bone scr 6.5x15 self-tap, 62411972.00625006540, bone scr 6.5x40 self-tap, 63745010.00625006530, bone scr 6.5x30 self-tap, 63523402.00625006540, bone scr 6.5x40 self-tap, 77002947.110010268, g7 osseoti multihole 60mm g, 6050381.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 10092.

Event Description

It was reported that the liner would not lock into the cup.Two different liners were used.There was a 1 hour delay in procedure as a result.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Concomitant medical products: biomet g7 freedom const e1 lnr 36mm e, item#: 010000983, lot#: 3453158.Complaint sample was evaluated and the reported event was confirmed.Visual inspection found multiple forms of damage, including indentations, scratches, and gouges.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.

• Brand Name: G7 FREEDOM CONST E1 LNR 36MM G
• 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: 7014600
• MDR Text Key: 91516412
• Report Number: 0001825034-2017-10091
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/06/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000985
• Device Lot Number: 3453182
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2015
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 93