MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FRDM CONST E1 +5MM LNR 36F; 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	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for the investigation.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a hip procedure, the liner was unable to be implanted into the shell.There was no reported harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional information on the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; g3; h2; h3; h4; h6.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified there is damage to the locking feature and visible impact marks on the outside radius.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.

• Brand Name: G7 FRDM CONST E1 +5MM LNR 36F
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12324232
• Report Number: 0001825034-2021-02396
• Device Sequence Number: 14487242
• Product Code: LPH
• UDI-Device Identifier: 00880304544673
• UDI-Public: (01)00880304544673(17)250429(10)6777830
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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 Expiration Date: 04/29/2025
• Device Model Number: N/A
• Device Catalogue Number: 110010292
• Device Lot Number: 6777830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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: UNK CUP.; UNK CUP