MAUDE Adverse Event Report: ZIMMER GMBH DURASUL, ALPHA INSERT, HOODED, II/32; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Discomfort (2330); Joint Dislocation (2374)

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10.Femoral head 12/14 taper 32 mm diameter +0 mm neck length item# 802203202 lot# 3047396.G2.Report source: australia.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.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2024-00126.

Event Description

It was reported that a patient underwent a hip arthroplasty.Subsequently, patient was revised approximately 14 months post implantation due to a dislocation.Acetabular component removed and revised.Diligence is complete and additional information on the reported event is unavailable at this time.

Event Description

It was reported that a patient underwent a hip arthroplasty.Subsequently, patient was revised approximately 14 months post implantation for a dislocation due to placement of primary acetabular component.Acetabular component removed and revised.Diligences is completed and no further information on the reported event has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d10, g3, g6, h2, h3, h6, h11.Femoral head 12/14 taper 32 mm diameter +0 mm neck length item# 802203202 lot# 3047396.Allofitâ®-s alloclassicâ®, shell with polar screw plug, uncemented, 52/ii item# 4265 lot# 3065418.Pictures of the explanted products were provided and reviewed during investigation.In picture where the products are assembled, it is possible to note a slight misalignment of the liner in the shell.However, it is impossible to conclude if this misalignment is the results of the explantation process during revision or it already took place during the time in vivo.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.An ap lower pelvis and a cross table lateral left hip taken before revision surgery were provided.The images were reviewed by a radiologist.A left hip arthroplasty is present with anatomic alignment.No dislocation, no signs of loosening, no radiolucency or any other contributing factor such as malalignment or patient anatomy that could confirm the reported event.There is no fracture or implant loosening.With the available information the event cannot be confirmed.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: DURASUL, ALPHA INSERT, HOODED, II/32
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 19034533
• MDR Text Key: 339271912
• Report Number: 0009613350-2024-00127
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024163010
• UDI-Public: (01)00889024163010(17)260131(10)3060690
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0100013509
• Device Lot Number: 3060690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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
• Treatment: SEE H10 NARRATIVE.; SEE H11 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male