MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 22/200; HIP PROSTHESIS

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source ¿ foreign ¿ austria.Associated products: item nr: 01.00405.00; lot nr: 2589790; name: revitan, conical nut.Item nr: 00-8775-028-02; lot nr: 2484201; name: biolox delta, ceramic femoral head, m, ø 28/0, taper 12/14.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 a patient underwent an initial hip replacement and approximately ten years later a revision surgery was performed due to a broken stem.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.Radiographs were provided but were of too poor quality to be reviewed by a health care professional, however it does confirm the implant fracture.A definitive root cause cannot be determined.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3,h10.Visual examination of the provided pictures confirms the distal stem has fractured close to the connection point, there's damage on the outer diameter most likely caused by excessive movement post stem fracture or during explantation.There are no signs of osseo-integration on either the distal or proximal components indicating possible lack of fixation.Based on the investigation, a pin fracture by fatigue of the distal revitan component can be confirmed.The absence of bone remains, points to lack of osseo-integration of distal and proximal component in vivo.Therefore, based on the examination of the devices, it is possible that loosening of the components contributed to the pin fracture by fatigue.Nevertheless, since the cause may be multifactorial, consisting of device-, patient- and procedure- related factors, a single definitive root cause could not be identified.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.D10 - medical devices: revitan proximal part 85; item# 01.00402.085; lot# 2546632.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.

• Brand Name: REVITAN, DISTAL PART, CURVED, UNCEMENTED, 22/200
• 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: 15526921
• MDR Text Key: 301007390
• Report Number: 0009613350-2022-00510
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024593077
• UDI-Public: (01)00889024593077(17)131031(10)2478049
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 01/20/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00406.222
• Device Lot Number: 2478049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 11/24/2022; 12/22/2022; 01/19/2023
• Supplement Dates FDA Received: 12/07/2022; 01/18/2023; 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2008
• 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
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention