MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL®, ALPHA INSERT, HH/32; HIP PROSTHESIS

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

It was reported that during surgery the inlay could not be secured in the cup.It was noticed that there was chipping of the anchoring groove at the edge of the inlay.The surgery was completed using new inlay.No consequences or impact to the patient.Due diligence is in progress for this complaint.Attempts have been made and no further information has been provided.

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

No additional event information.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

• Brand Name: DURASUL®, ALPHA INSERT, HH/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: 17841627
• MDR Text Key: 324561192
• Report Number: 0009613350-2023-00543
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024413603
• UDI-Public: (01)00889024413603(17)280224(10)3147027
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

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 Model Number: N/A
• Device Catalogue Number: 01.00013.408
• Device Lot Number: 3147027
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2023
• 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 Age: 49 YR
• Patient Sex: Female