MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 52E; PROSTHETIC, HIP

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	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the liner could not assemble the cup.The surgery was completed using a bigger cup and corresponding liner.There was a 31 minute delay.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).G2: foreign: china.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00738.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.Device in process to return.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected visual examination of the provided pictures identified the shell has minor scuffing.No additional details can be seen.Unable to confirm complaint.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; d9; g3; h2; h3.Visual examination of the returned product identified the locking feature of the shell has a piece of debris lodged inside.The liner shows damage to the locking feature.It is unknown if the debris was present during the assembly attempts or during removal of the shell.Complaint confirmed based on evaluation of returned product.A definitive root cause cannot be determined.The returned shell has debris present in the inner radius locking groove which would have caused or contribute to the reported event.Per the g7 acetabular system surgical technique (0190.1-ous-en-rev0516) page 24 - polyethylene liner insertion "ensure the interior of the shell is dry and free of debris and overhanging soft tissue is removed." not cleaning the shell prior to insertion attempts would be considered off-label usage, however, it could not be confirmed when the debris was generated as the shell was explanted after attempting to seat the liner.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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: G7 PPS LTD ACET SHELL 52E
• Common Device Name: PROSTHETIC, 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: 16672677
• Report Number: 0001825034-2023-00734
• Device Sequence Number: 5377689
• Product Code: PBI
• UDI-Device Identifier: 00880304524224
• UDI-Public: (01)00880304524224(17)321018(10)7356943
• 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,Followup
• Report Date (Section B): 08/07/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000663
• Device Lot Number: 7356943
• 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: 03/11/2023
• Supplement Date Received by Manufacturer: 04/14/2023; 07/28/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 04/17/2023; 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 010000857 G7 NEUTRAL E1 LINER 36MM E LOT: 7365451.
• Patient Sex: Prefer Not To Disclose