MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN®, PROXIMAL PART, CONICAL, UNCEMENTED, 55, TAPER 12/14; HIP PROSTHESIS

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 02/20/2023

Event Type  Injury  

Event Description

It was reported that patient underwent revision due to pain.During the procedure, the femoral shaft was found to be loose with a large amount of black debris in the joint.All components were replaced without complication.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Report source: foreign-germany.Concomitant medical products: associated products: item number: 01.00402.055, lot number: unknown, item name: revitanâ®, distal part, curved, uncemented, 16/140.Item number: unknown, lot: unknown, item name: unknown sulox head 28.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00119.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Upon reassessment of the reported event, it was determined a medwatch report should not have been filed because the proximal part was not contributing to the event given this information, this medwatch will be voided.

Event Description

As it comes from initial visual examination, it can be concluded that the distal component is the faulty part involved in the reported event and not the proximal component.Given this information this medwatch will be voided.

• Brand Name: REVITAN®, PROXIMAL PART, CONICAL, UNCEMENTED, 55, TAPER 12/14
• 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: 16596221
• MDR Text Key: 311821595
• Report Number: 0009613350-2023-00120
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024502956
• UDI-Public: (01)00889024502956(10)120731(17)2402536
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00401.055
• Device Lot Number: 2402536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2007
• 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): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 85 KG