MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH DURASUL®, ALPHA INSERT, II/36; PROSTHESIS, HIP

Catalog Number 01.00013.709

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2-foreign- germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that inside the sterile packaging there was a handwritten note.Customer implanted the product in the patient anyway.This event could potentially lead to serious injury.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

At the time of submission for this complaint, no product (packaging) was provided to the product surveillance team for further investigation or review.However, two photographs were received.One image shows the affected tyvek lid with the reported handwritten note ¿humerus2023*¿ in ballpoint pen.Additionally, there are several blood stains seen on the lid.The second received image shows the product label of the involved durasul alpha insert.A review of the device manufacturing records confirmed no abnormalities or deviations review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Based on the received images, the reported event can be confirmed.The root cause of the reported issue is attributed to a packaging/manufacturing issue, whereby a tyvek lid with the word ¿humerus2023*¿ written in ballpoint pen was erroneously used during the packaging of the durasul alpha insert in the clean room.The sterility of the device is not expected to be compromised due to the reported event, as the device was verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.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

No additional information at this time.

• Brand Name: DURASUL®, ALPHA INSERT, II/36
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER 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: 17807239
• MDR Text Key: 324130814
• Report Number: 0009613350-2023-00530
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024413627
• UDI-Public: (01)00889024413627(17)280603(10)3157478
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/21/2023

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 Catalogue Number: 01.00013.709
• Device Lot Number: 3157478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2023
• 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 Sex: Prefer Not To Disclose