MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. MULTIPOLAR SHELL 46 MM O.D; PROSTHETIC, 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	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when assembling the final shell and liner with the metal head, there was a defect in the liner.The metal head was pushed into the liner with a little difficulty.It was unable to be inserted by hand and had some damage when trying to snap in.30 minutes were spent trying to assemble the device.Everything was snapped into the patient after malleting really hard which may have damaged the mechanisms inside.The metal head was not running as freely as it should be.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 00500104428 item name liner 28 mm i.D.For use with 44/45/46 mm o.D.Shells lot # 65537646.802202801 item name femoral head 12/14 taper 28 mm diameter -3.5 neck length lot # 3107839.G2: foreign: malaysia.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the head, liner, and shell did not fully assemble properly.The video further shows that the devices were not assembling properly by hand.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.This complaint was confirmed based on the provided pictures and video of the assembly issue.A definitive root cause cannot be determined for the assembly issue.It was indicated that the devices were likely damaged after hitting the devices very hard but implanted anyway.Per surgical technique, the only time this construct should be impacted is if the construct is assembled together on the back table and needs to be impacted onto the stem.Otherwise, the devices should just snap together and an impactor is not indicated for use for assembly.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.

• Brand Name: MULTIPOLAR SHELL 46 MM O.D
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19629412
• Report Number: 0002648920-2024-00208
• Device Sequence Number: 12536019
• Product Code: KWY
• UDI-Device Identifier: 00889024115347
• UDI-Public: (01)00889024115347(17)330117(10)65761501
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K833991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/08/2024

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 Model Number: N/A
• Device Catalogue Number: 00500104600
• Device Lot Number: 65761501
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose