MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE F HIGH WALL LINER; 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	04/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 110017104, g7 finned shell, 7083368.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product was used and remains implanted.The investigation is in process.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 surgeon has trouble getting the liner to insert into the cup.After several hits, the surgery was finally able to get the liner in and completed the surgery as intended.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 event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: g3; h2; h3; h6.Radiographs were provided and reviewed by a health care professional.Review of the available records identified expected postoperative appearance from a recently placed left total hip arthroplasty.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not 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: 36MM I.D. SIZE F HIGH WALL LINER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14375072
• Report Number: 0001822565-2022-01412
• Device Sequence Number: 2007450
• Product Code: LPH
• UDI-Device Identifier: 00889024520493
• UDI-Public: (01)00889024520493(17)2691017(10)65234015
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/17/2022

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: 30123606
• Device Lot Number: 65234015
• 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: 04/21/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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
• Patient Age: 44 YR
• Patient Sex: Male