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 Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 01/26/2022

Event Type  Injury  

Manufacturer Narrative

Therapy date: (b)(6) 2022.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.X-rays were received and will be reviewed as part of ongoing investigation.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00109.

Event Description

It was reported that the patient underwent revision surgery due to dislocation/disassociation.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Based on the provided information and the visual examination, the taper connection between the connection pin and the proximal part of the revitan stem became loose.The reason for this loosening is unknown and no comments can be made at what point in time the taper connection became loose.Because of the loosening of the taper connection the proximal part was able to move against the connection pin.The connection pin¿s repetitive contact with the proximal part after the loosening led to wear on the inner diameter of the proximal part, and most likely also caused damage to the connection pin.As a consequence of the wear, the proximal part was able to tip medially.One unlabelled ct image was provided of low image quality for the bone structure due to limited resolution and image artifacts.As there is no clinical information available (e.G.Patient medical history, or a complete x-ray follow-up to assess any potential bone changes and loosening of the proximal part over time) the background of this case remains unknown.A review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.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.

• 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: 13771362
• MDR Text Key: 287247342
• Report Number: 0009613350-2022-00156
• Device Sequence Number: 1
• Product Code: KWA
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00401.055
• Device Lot Number: 2462550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2008
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male