MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH FITMORE, SHELL WITH FINS, UNCEMENTED, 56/KK; HIP PROSTHESIS

Model Number N/A

Device Problem Malposition of Device (2616)

Event Date 09/25/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 ¿ durasul, alpha insert, hooded, kk/32, item# (b)(6), lot# 2937776.Biolox delta, ceramic femoral head, m¸ 32/0, taper 12/14, item# (b)(6), lot# 3103772.Cls spotorno, stem, 145, uncemented, 6.0, taper 12/14, item# (b)(6), lot# 3048483.G2 ¿ foreign ¿ australia.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00593.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent revision surgery on the left hip a year and six days post implantation due to anterior impingement caused by cup positioning.Attempts have been made and no further information has been provided.

Event Description

It was reported that the patient underwent revision surgery on the right hip a year and six days post implantation due to anterior impingement caused by cup positioning.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h4, h6.No product was returned, or pictures provided; visual evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.The reported products were reviewed for compatibility with no issues noted.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.One ap pelvis overview was received and reviewed a radiologist.The review identified bilateral total hip arthroplasties with possible radiolucency along the medial aspect of the right acetabular cup which could indicate loosening, as well as shallow appearance of the right acetabular cup (right acetabular inclination angle is 42°) and small size of the femoral head.Based on the provided information, the reported impingement could not be confirmed, but radiolucency along the medial aspect of the right acetabular cup which could indicate loosening.Based on the information at hand, a root cause for the loosening could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00593-2.

Event Description

Diligence is complete and to date no additional information is available.

• Brand Name: FITMORE, SHELL WITH FINS, UNCEMENTED, 56/KK
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17963344
• MDR Text Key: 326004797
• Report Number: 0009613350-2023-00592
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024384231
• UDI-Public: (01)00889024384231(17)240731(10)3002582
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• 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,Followup,Followup
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00024.456
• Device Lot Number: 3002582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 10/04/2023; 01/31/2024
• Supplement Dates FDA Received: 10/30/2023; 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 88 KG