MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 48C; PROTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after implanting the g7 48mmc acetabular cup into the patient's body, the surgeon found that the screw holes had slipped, and the plug could not be firmly screwed in.The corresponding e1 32mm sizec acetabular liner was then inserted into the acetabulum, and it was found that the acetabular liner could be flushed with the edge of the acetabular cup, but it did not lock into place.When tested with vascular forceps, the acetabular liner was able to be removed with a single pinch.The doctor finally removed the 48mm acetabular cup and replaced it with a 50mm acetabulum and the corresponding liner which fit securely causing a twenty-minute delay of procedure.
Additional Manufacturer Narrative
(b)(4).D10: 010000925 g7 hi-wall e1 liner 32mm c 7485855.G2: foreign: china.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02610.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h3, h4, h6 visual examination of the returned product identified no damage to the shell.The liner has visible damage to the locking feature.All 4 screw plugs are installed.The apical plug is fully installed and is not sitting proud.Every corner of the hex feature has damage to it and rolled material is present.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.This complaint was confirmed based on the damage on both the dome hole plug and liner from attempted use.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 or Problem Description
No additional event information to report at this time.

• Brand Name: G7 PPS LTD ACET SHELL 48C
• 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: 18072972
• Report Number: 0001825034-2023-02609
• Device Sequence Number: 7665738
• Product Code: PBI
• UDI-Device Identifier: 00880304524200
• UDI-Public: (01)00880304524200(17)330104(10)7384811
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 010000661
• Device Lot Number: 7384811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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 Age: 68 YR
• Patient Sex: Female