MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH IMPACTION HANDLE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	6541-4-810
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	12/27/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
During the tka procedure, a metal plug fell out of the patient's body from the triathlon 6541-4-810 handle.One year after the surgery, the patient was referred for another surgery to remove the part from the triathlon handle.Photos attached.Update: the plug cut was not into the insert.The insert was revised as a standard procedure.Left side.
Event or Problem Description
During the tka procedure, a metal plug fell out of the patient's body from the triathlon 6541-4-810 handle.One year after the surgery, the patient was referred for another surgery to remove the part from the triathlon handle.Photos attached.Update: the plug cut was not into the insert.The insert was revised as a standard procedure.Left side.
Additional Manufacturer Narrative
An event regarding foreign matter involving a impaction handle was reported.The event was confirmed upon visual inspection.Method & results product evaluation and results: visual inspection: visual inspection of the returned device noted the following: the pin that was allegedly left in the patient was returned.The full impaction handle was not returned.Examination of the returned device with the engineer indicated that damage is consistent with repeated contact with tissue in the patient's body.This is unrelated to the separation from the full impaction handle.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional inspection: dimensional inspection was not performed because the device was returned damaged.Functional inspection: functional inspection was not performed because the event does not relate to device function.Material analysis: material analysis is not performed as this is not related to material integrity.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the 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 becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: IMPACTION HANDLE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9412259
• Report Number: 0002249697-2019-03942
• Device Sequence Number: 4220790
• Product Code: JWH
• UDI-Device Identifier: 07613327240603
• UDI-Public: 07613327240603
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K143393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 6541-4-810
• Device Catalogue Number: 6541-4-810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention