MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 60G; PROTHESIS, HIPS

Model Number N/A

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It was reported during the hammering of the shell, it was impossible to unscrew the shell from the impactor.No known consequences or impact to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10:110003450 g7 str monoblock shell insrtr 493800.G2: foreign: poland multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 03000.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 additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified the inserter shows damage to the shaft and the strike plate.Due to the damage of the threads of the inserter no function check could be performed.The threads of the shell show scuffing and signs of use so no function check could be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Medical records were not provided.A definitive root cause cannot be determined.Complaint confirmed based on evaluation of the returned products.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 60G
• Type of Device: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): .; 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: 18344531
• MDR Text Key: 330793954
• Report Number: 0001825034-2023-02999
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524262
• UDI-Public: (01)00880304524262(17)330921(10)7499859
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• 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: 010000667
• Device Lot Number: 7499859
• 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: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• 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.