MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALLOFIT ALLOCLASSIC SHL 54/JJ; HIP PROSTHESIS

Catalog Number 4246

Device Problem Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Date 07/07/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision one year after the initial implantation due to instability.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10 - medical devices: durasul, alpha insert, hooded, jj/28; item# 01.00013.310; lot# 2982091.G2 - foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00465.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

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed.The implants present in the x-rays provided were the patient's initial components and not the same implants in totality present at the time of revision.This information would not enhance the investigation of the current allegation.With the available information, a definitive root cause cannot be determined.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: ALLOFIT ALLOCLASSIC SHL 54/JJ
• 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: 17570936
• MDR Text Key: 321403328
• Report Number: 0009613350-2023-00466
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024166035
• UDI-Public: (01)00889024166035(17)260715(10)3076352
• 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
• Report Date: 10/06/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 4246
• Device Lot Number: 3076352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male