MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 10 DEG E1 LINER 36MM D; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Event Description

It was reported that the surgeon implanted g7 bonemaster shell, 1 screw, high wall liner and then a + 10 degree liner.The surgeon implanted the cup, inserted 25mm bone screw then went to put in high wall liner.There was solid impact on liner engagement but immediately after, the liner disengaged.The surgeon thought it was the screw, so he removed it and then put it back in, making sure it fully seated again.He then attempted to impact liner for a 2nd time, and it would not engage.He was asked to check soft tissue impingement and check the screw again.The surgeon followed all tips/instructions on placing the liner and screw correctly, and he didn¿t see any soft tissue impingement but cleared any soft tissue in vicinity.He then decided to remove the screw and replace the liner and again, the liner initially engaged and then when trialing, it disengaged a third time.The surgeon was offered to replace the liner with a new liner (10 degree) and he impacted that into existing cup.The liner disengaged twice more upon trialing.The surgeon was advised to remove the cup and put in a new cup, which he did, and he once again tried to impact existing liner.The liner once again disengaged.It was then suggested to open a new liner and he impacted that liner and it stayed engaged.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Report source, foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00375 & 0001825034-2023-00377.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.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d4; g3; h2; h4 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

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 no visible damage to the shell.The liners both have visible damage to the scallop areas.There was no damage to the locking feature of either liner.It is unknown if the damage occurred during or prior to assembly attempts.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.The additional information does not change the outcome of the previous investigation.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.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Unable to confirm complaint.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.

• Brand Name: G7 10 DEG E1 LINER 36MM D
• 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: 16432778
• MDR Text Key: 310364816
• Report Number: 0001825034-2023-00376
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526754
• UDI-Public: (01)00880304526754(17)230410(10)6275256
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000895
• Device Lot Number: 6275256
• 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: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2018
• 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