MAUDE Adverse Event Report: ZIMMER GMBH REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 16/140; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10.Unknown proximal revitan component unknown biolox head g2.Report source: germany.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that fracture of the cone on the distal implant occurred approximately 1 month ago.Revision surgery is planned.Attempts have been made and no further information has been provided.

Event Description

It was reported that a patient had an initial right total hip arthroplasty on an unknown date with unknown products and the head and stem were subsequently revised due to osteolysis and erosion of the proximal femur.Approximately 9 years post-revision, the patient felt a pain in his hip.A second revision of the femoral stem was performed and it was confirmed that the proximal cone was broken and loose while the distal stem was well-ingrown.An osteotomy was performed to remove the femoral components, which were stabilized with cerclage wires.A new liner was attempted; however, this would not seat, so the original liner was placed back in.The procedure was completed without further complications.Diligence is complete and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10.Unknown proximal revitan component.Unknown biolox head.Unknown cement.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.

• Brand Name: REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 16/140
• 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: 18628720
• MDR Text Key: 334368670
• Report Number: 0009613350-2024-00026
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024592957
• UDI-Public: (01)00889024592957(17)180228(10)2695455
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 0100406116
• Device Lot Number: 2695455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2013
• 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; Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 82 KG