MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS; PROSTHETIC, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign: malaysia.Multiple mdr reports were filed for this event, please see associated reports 0001822565 - 2024 - 00617.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device remains implanted.

Event 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.

• Brand Name: LINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS
• Type of Device: 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: 18777258
• MDR Text Key: 336536686
• Report Number: 0002648920-2024-00046
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00500104428
• Device Lot Number: 65537646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN SHELL
• Patient Sex: Prefer Not To Disclose