MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE II ELEVATED RIM LINER USE WITH 52MM O.D. SIZE II SHELL; PROTHESIS, HIPS

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	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) d10: unknown neutral liner unknown g2: foreign: india multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 02737 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 elevated liner did not fit properly inside of the cup.The surgeon was able to reduce the hip in the final trial and the elevated liner came out easily.The surgeon tried a neutral liner.The neutral liner was also not fitting initially.The neutral liner was able to fit partially after three to four attempts.Attempts for additional information have been made and none has been provided.
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 and/or corrected information.D10: 00875101036 36mm i.D.Size ii neutral liner use with 52mm o.D.Size ii shell 65337424.Visual examination of the returned product identified there are circular indentations on the outside radius of the liner.There is also damage to the locking feature of the device.The neutral liner remains implanted.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined for the liners not seating properly.User error was identified as it was stated the surgery was completed with the liner only fitting partially.As per the trilogy it acetabular system surgical technique it is required to verify liner seating prior to completing the surgery.As per the longevity it highly crosslinked liner, improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions reducing the service life of the prosthetic implants.This complaint was confirmed based on the signs of use on the returned liner.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.

• Brand Name: 36MM I.D. SIZE II ELEVATED RIM LINER USE WITH 52MM O.D. SIZE II SHELL
• Common Device Name: PROTHESIS, HIPS
• 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: 17878498
• Report Number: 0001822565-2023-02736
• Device Sequence Number: 20756916
• Product Code: LZO
• UDI-Device Identifier: 00889024149724
• UDI-Public: (01)00889024149724(17)280312(10)65918779
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093846
• 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
• Report Date (Section B): 01/11/2024

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: 00875201036
• Device Lot Number: 65918779
• 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: 09/15/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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
• Patient Age: 76 YR
• Patient Sex: Female