MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIT E NEUTRAL LNR 36MM F; PROTHESIS, 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	06/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 110017104 g7 finned 4 hole shell 54f 7498899.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 the liner would not seat in the cup properly.Surgeon had a clear view of the cup but stated there was an issue with the ridge around the liner, which prevented the liner from being completely impacted.A new liner was opened with the same lot number to complete the case with no issues.No known impact or consequence to the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified nicks and gouges are noted to the anti rotation scallops, outer spherical sides, and locking feature.Burrs were noted to the locking feature of the liner.Scratches are noted around the face and inner / outer spherical surfaces from attempted use.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.This complaint was confirmed based on the returned device.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 VIT E NEUTRAL LNR 36MM F
• Common Device Name: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17370303
• Report Number: 0001822565-2023-01976
• Device Sequence Number: 17109488
• Product Code: LPH
• UDI-Device Identifier: 00889024519916
• UDI-Public: (01)00889024519916(17)280410(10)65931951
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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: 30103606
• Device Lot Number: 65931951
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Patient Sex: Male