MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GUEPAR I-II. CIRCLIP; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 2080-04

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 09/19/2022

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

The clip has somehow come off and the adapter is floating.The clip was dislodged after the previous operation ((b)(6) 2021) and we were informed that it would be replaced on (b)(6) 2022 when we were contacted this time.This clip was supposed to hold the joint axis connecting the femur and tibia, but since it came off, the joint axis is floating.The clip could be removed during surgery.

Manufacturer Narrative

Reported event an event regarding disassociation involving a guepar i-ii circlip was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection indicated the circlip was returned in a used state.Minor scratches are observed on the device surface consistent with attempted explantation/implantation.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: event description: the clip has somehow come off and the adapter is floating.Update: the clip was dislodged after the previous operation and we were informed that it would be replaced on (b)(6) 2022 when we were contacted this time.This clip was supposed to hold the joint axis connecting the femur and tibia, but since it came off, the joint axis is floating.The clip could be removed during surgery.Revision due to poly wear.Unlabelled/undated x-ray: ap distal femur and proximal tibia, tumor style implant with proximal tibia replacement and distal femoral replacement.The axle looks proud.Conclusion of assessment: no conclusions may be made without additional information.Root cause and confirmation: no root cause of confirmation can be made with the limited information provided.-device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: visual inspection indicated the circlip was returned in a used state.Minor scratches are observed on the device surface consistent with attempted explantation/implantation.A review of the provided medical records by a clinical consultant stated the following comment: stryker pi: 3116812 and 3133206 event description: the clip has somehow come off and the adapter is floating.Update: the clip was dislodged after the previous operation and we were informed that it would be replaced on (b)(6) 2022 when we were contacted this time.This clip was supposed to hold the joint axis connecting the femur and tibia, but since it came off, the joint axis is floating.The clip could be removed during surgery.Revision due to poly wear.Unlabelled/undated x-ray: ap distal femur and proximal tibia, tumor style implant with proximal tibia replacement and distal femoral replacement.The axle looks proud.Conclusion of assessment: no conclusions may be made without additional information.Root cause and confirmation: no root cause of confirmation can be made with the limited information provided.Further information such as pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.Correction: d6b.

Event Description

The clip has somehow come off and the adapter is floating.The clip was dislodged after the previous operation ((b)(6) 2021) and we were informed that it would be replaced on (b)(6) 2022 when we were contacted this time.This clip was supposed to hold the joint axis connecting the femur and tibia, but since it came off, the joint axis is floating.The clip could be removed during surgery.

• Brand Name: GUEPAR I-II. CIRCLIP
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15585192
• MDR Text Key: 301555754
• Report Number: 0002249697-2022-01470
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 2080-04
• Device Lot Number: G7272515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male