MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 65, TAPER 12/14

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: item# 0100401065, lot# unknown, revitanâ®, proximal part, conical, uncemented, 65, taper 12/14.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.(b)(4).

Event Description

It was reported that a patient underwent revision surgery due to implant fracture.Additional information has been requested, but is not available at this time.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that the patient was implanted with a revitan stem on an unknown date in 2011 and underwent a revision of the stem in 2020 due to implant fracture in the area of the connection.Review of received data: no medical data relevant to the case has been received.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check could not be performed due to missing product identification.Dhr review: review of the device history records could not be performed due to missing reference and lot number.Conclusion: it was reported that the patient was implanted with a revitan stem on an unknown date in 2011 and underwent a revision of the stem in 2020 due to implant fracture in the area of the connection.As the implant failure was reported to be in the area of the connection it is most likely involving the distal revitan component, of which we have not received any reference or lot number.Neither did we received any x-rays, operative notes, office visit notes, therefore, relevant patient and procedure related factors that may have affected the performance of the components such as bone quality, activity level, type of activity, relevant medical history, patient anatomy, implant positioning and changes in patient anatomy and implant positioning during the time in-vivo are unknown.Further, neither the device(s) nor photos of the device(s) were received; therefore, visual and dimensional evaluation could not be performed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).In conclusion based on the significant lack of information an in-depth investigation could not be performed.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation has been completed.

Manufacturer Narrative

Additional information which was received on nov 12, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additionals: a2, d1, d2, d4, d7.Corrections: b4, b5, g4, g7, h10.The manufacturer received revision report(available in french) for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

It was reported that a patient underwent revision surgery due to implant fracture.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.It has been realized that a different product is the main product of this case.The incident is newly reported with 0009613350-2021-00346.Therefore, this mdr is obsolete.Please invalidate the case from your system.Zimmer¿s reference number of this file is (b)(4).

Event Description

See h10.

• Brand Name: REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 65, TAPER 12/14
• Type of Device: REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 65, TAPER 12/14
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10585848
• MDR Text Key: 208506177
• Report Number: 0009613350-2020-00424
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.00401065
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention