MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL, ALPHA INSERT, HOODED, KK/32; 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 ¿ fitmore, shell with fins, uncemented, 56/kk, item# (b)(6), lot# 3002582.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: 0009613350-2023-00592.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.

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.

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 additional information.The following sections were updated/corrected: b4, b5, g3, g6, h2, h6.Upon reassessment of the reported event, it was determined to be not reportable as this device is not contributory to the reported event.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable as this device is not contributory to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: DURASUL, ALPHA INSERT, HOODED, KK/32
• 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: 17963743
• MDR Text Key: 326005341
• Report Number: 0009613350-2023-00593
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024507609
• UDI-Public: (01)00889024507609(17)230131(10)2937776
• 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 Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.00013.511
• Device Lot Number: 2937776
• 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: 02/05/2018
• 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