MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE GG ELEVATED RIM LINER USE WITH 48MM O.D. SIZE GG SHELL; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the installation of the longevity liner, there was no snapping and full installation.Subsequently, there was a 30-minute surgical delay, and the liner was exchanged by another liner of the same item.The surgical technique for the product was utilized, and there were no reported contributing conditions related to the event.No patient information was provided.No additional information was available.
Additional Manufacturer Narrative
(b)(4).Foreign: kazakhstan.Cat# 00875304801 lot# unknown 48mm o.D.Size gg porous uncemented with cluster holes shell cat# 00-8018-032-05 lot# unknown femoral head +10.5x32mm dia cat# 2843 lot# unknown alloclassic sl stem 3 12/14 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
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h4;h6 no product was returned; however, a picture was provided.A visual examination of the picture identified a liner within a clear bag.No further evaluation can be made from the provided picture.Medical records were not provided.The reported products were reviewed for compatibility with no issues noted.A review of the device history records identified no deviations or anomalies during manufacturing.This issue could not be confirmed, and 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
There is no update to the prior event description provided.
Additional Manufacturer Narrative
Visual examination of the returned product identified the locking feature was damaged.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Root cause unchanged.This complaint was confirmed based on the damage to the returned device.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: 32MM I.D. SIZE GG ELEVATED RIM LINER USE WITH 48MM O.D. SIZE GG SHELL
• 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: 16976565
• Report Number: 0001822565-2023-01367
• Device Sequence Number: 17762508
• Product Code: LPH
• UDI-Device Identifier: 00889024149670
• UDI-Public: (01)00889024149670(17)260610(10)64933347
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• PMA/510(K) Number: K123019
• 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): 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: Health Professional
• Device Expiration Date: 06/10/2026
• Device Model Number: N/A
• Device Catalogue Number: 00875200832
• Device Lot Number: 64933347
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 08/11/2023; 01/10/2024
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 08/11/2023; 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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
• Patient Sex: Unknown