MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 56F; PROTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: unknown g7 shell inserter unknown g2: foreign: australia multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00303 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 or Problem Description
It was reported that during a zimmer biomet hip replacement, the g7 cup was implanted using a straight g7 shell insertion handle.The g7 implant cold-welded to the insertion handle, and no one could unscrew it.The handle with the g7 implant had to be removed.A new g7 cup was opened, and the curved insertion handle was used to insert the second implant into the patient.No known impact or consequence to the patient.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.One g7 pps ltd acet shell 56f item# 010000665 lot# 7504674 and one g7 str monoblock shell insrtr item# 110003450 lot# 619980 were returned and evaluated.Upon inspection the devices were stuck together and could not be separated for evaluation of the threads.There is scuffing to the shaft and indentations to the strike plate of the inserter.There was no visible damage to the shell.A review of the device history records identified no related deviations or anomalies during manufacturing.A review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.The event is confirmed via returned product review.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.

• Brand Name: G7 PPS LTD ACET SHELL 56F
• Common Device Name: PROTHESIS, HIPS
• 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: 18640470
• Report Number: 0001825034-2024-00300
• Device Sequence Number: 18159324
• Product Code: PBI
• UDI-Device Identifier: 00880304524248
• UDI-Public: (01)00880304524248(17)330911(10)7504674
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 010000665
• Device Lot Number: 7504674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/14/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Weight: 132 KG