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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2023

Event Type  malfunction  

Event Description

It was reported that a 58 multihole g7 cup was placed in the acetabulum with screws.A freedom liner was requested, and a g freedom liner was used.The liner would not engage after 4 attempts.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: cat# 31-323250, lot# 534200, 3.2mmx50mm rnglc+ acet drl bit; cat# 00-6250-065-20, lot# j7415447, bone screw 6.5x20 selftap; cat# 11-300816, lot# 097220, arcos 16x150mm spl tpr dist; cat# 110010267, lot# 65375071, g7 osseoti multihole 58mm g; cat# 00-6250-065-20, lot# 65349395, bone screw 6.5x20 selftap; cat# 00-6250-065-60, lot# 65746064, bone screw 6.5x60 selftap; cat# 00-6250-065-15, lot# j7131464, bone screw 6.5x15 selftap; cat# 00-6250-065-20, lot# j7426206, bone screw 6.5x20 selftap; cat# 00-6250-065-20, lot# j7161142, bone screw 6.5x20 selftap; cat# 110031001, lot# 65475291, longevity dm bearing 28x46mm; cat# 11-301332, lot# 273820, arcos con sz b hi 70mm; cat# 110024465, lot# 239830, g7 dual mobility liner 46mm g; cat# 650-1158, lot# 3133312, delta cer fem hd 28/0mm t1.The 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d9; g3; h2; h3; h6 visual examination of the returned product identified there are indentations on the od and to the locking feature of the device.It is unknown if the damage occurred during or prior to the assembly attempts.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot 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.

Event Description

No further information at the time of this report.

• Brand Name: G7 FREEDOM CONST E1 LNR 36MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16844981
• MDR Text Key: 314306128
• Report Number: 0001825034-2023-00907
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304989092
• UDI-Public: (01)00880304989092(17)260528(10)7037178
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• 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: 010000985
• Device Lot Number: 7037178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• 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 Sex: Female