MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM D; PROTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/16/2023

Event Type  malfunction  

Event Description

It was reported during the operation acetabular contusion grinding to 49-50 after the placement of size 50 g7 cup.The inside of the cup socket was cleaned out after the prothesis e1 high side liner d model, the director of the operation knock found that the g7 cup and the liner still did not lock.The liner was still able to clip out after repeated checks.The force of the knock and the angle of striking the liner, the liner still cannot lock, after up to 10 minutes repeating checks.After repeated checks and cleanups, the liner still could not be locked, and finally the liner was punched in, and the stem was started.The stem of the femoral prosthesis was put on, and the liner was found to have fallen out and not lock with the outer cup when it was reset with the femoral head trial mold.After repeated checks, the liner was tapped again, and the liner still could not be locked.After long and repeated checks and cleanups, the liner still could not be locked.After discussing the results, the ceramic liner size d model was removed, and it was punched in at once.Finally, after discussing the results, the ceramic liner size d model was removed, and the operation was completed with a single blow.The director questioned the locking mechanism and quality of this product, which prolonged the operation and caused the patient to bleed.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: 010000662 g7 pps ltd acet shell 50d 7151488.110003621 biolox delta cer lnr 32mm d 3101937.G2: foreign: china.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 and/or corrected information.Visual examination of the returned product identified a gouge and an inclusion on the inner radius of the liner.The barb has been roughed up in 2 locations around the diameter.Tool marks were observed in multiple locations around the diameter.Light surface scratching was observed on the outer radius.No evidence was observed that indicates the liner came in contact with an unseated screw during impaction.Unable to confirmed complaint as the shell was not returned or images provided.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

• Brand Name: G7 HI-WALL E1 LINER 36MM D
• Type of Device: PROTHESIS, 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: 16691569
• MDR Text Key: 313144990
• Report Number: 0001825034-2023-00765
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527096
• UDI-Public: (01)00880304527096(17)270901(10)7334170
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 010000934
• Device Lot Number: 7334170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 82 KG