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 Joint Laxity (4526); Insufficient Information (4580)

Event Date 12/06/2022

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Clip disengaged.The patient has had multiple revisions prior so revision is undecided now.

Event Description

Clip disengaged.The patient has had multiple revisions prior so revision is undecided now.

Manufacturer Narrative

Reported event: an event regarding disassociation involving a guepar i-ii circlip was reported.The event was confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review with clinical consultant indicated "confirmation: it does appear that there is a loose clip floating freely in the knee on a single view image.The nature of the clip cannot be determined.Root cause: a root cause cannot be ascertained from the materials provided for review." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: clinician review of provided x-rays confirmed the reported event.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.

• 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: 16039841
• MDR Text Key: 306063922
• Report Number: 0002249697-2022-01887
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2080-04
• Device Lot Number: G7920612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Male