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

Catalog Number	010000934
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up mdr will be submitted.Report source: (b)(6).
Event or Problem Description
It was reported that during an initial hip procedure the liner would not seat in the shell.It was noted after the acetabulum was fixed to 49 during the operation, a no.50 g7 cup was placed and two 15mm screws were implanted.Then the liner of the trial was inserted.The handle part used the no.11 echo handle and the 36/0 test head.The surgeon struck the liner after checking the screw at the bottom of the acetabulum and found the g7 liner would not lock.The surgeon began to clean up the cup surrounding soft tissue, bone, fat, and once again, checked whether the screw is tight.Still the liner would not lock into place, after an hour-long repeatedly.A new liner was opened and inserted successfully.The stem and head were then inserted to complete the operation.A 60-minute delay and blood loss of 800 ml was noted.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One g7 hi-wall e1 liner 36mm d item# 010000934 lot# 6839502 was returned and evaluated.Upon visual inspection, the locking feature has some indentation along with the outer radius.The provided pictures that were taken during the procedure also confirm the reported event as it can be seen that the liner is not fully seated in the cup.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues as an undated initial op note states no complications were noted, the reported allegation was not mentioned in the revision dictation as the operation went smoothly and an ebl of 800 ml with delay of 60 min.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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 HI-WALL E1 LINER 36MM D
• Common Device Name: 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: 12300596
• Report Number: 0001825034-2021-02328
• Device Sequence Number: 3807533
• Product Code: LPH
• UDI-Device Identifier: 00880304527096
• UDI-Public: (01)00880304527096(17)250810(10)6839502
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2025
• Device Catalogue Number: 010000934
• Device Lot Number: 6839502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 60 KG