MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 38MM C; PROSTHESIS, 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	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2023-00106.
Event or Problem Description
It was reported that the issue was a both a seating issue and technical error.There was a problem with the soft tissue and surgical technique (care of soft tissue).At first, the soft tissue and surgical technique resulted in a mis-placed metal liner.The surgeon then tried to remove the metal liner but was unable to remove it using the normal technique, and direct tapped the metal liner.The surgeon's tapping made it even more difficult to remove.The surgeon finally removed the shell and liner together.The surgeon pointed out that there was no way to make the extraction easier.There were no comments from the surgeon whether there were any patient contributing conditions related to the event.It was also reported that the surgical techniques were utilized, but it is possible that there were a few mistakes.Information regarding any patient effects was not available from the surgeon.The surgeon completed the surgery using other products.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d4;g3;h2;h3;h4;h6 a visual examination of the returned g7 osseoti 3 hole shell identified damage to the lip of the device, and a scratch to the inner radius.It is unknown if the damage occurred prior or during the assembly attempts.An examination of the provided pictures of the liner showed that it had a large dent and many scratches.Medical records were not provided.A review of the device history records identified no deviations or anomalies during manufacturing.The reported products were also reviewed for compatibility, and no issues noted.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
No further event information is available at the time of this report.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).The additional information does not change the outcome of the previous investigation.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 DUAL MOBILITY LINER 38MM C
• Common Device Name: PROSTHESIS, 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: 16225466
• Report Number: 0001825034-2023-00104
• Device Sequence Number: 12099981
• Product Code: LPH
• UDI-Device Identifier: 00880304703490
• UDI-Public: (01)00880304703490(17)321011(10)997090
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150522
• 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): 10/19/2023

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: 110024461
• Device Lot Number: 997090
• Was Device Available for Evaluation?: No
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 03/07/2023; 10/18/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 03/09/2023; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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
• 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