MAUDE Adverse Event Report: STRYKER GMBH #3 BIPOLAR RADIAL HEAD IMPLANT (STERILE PACKED); ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number RCNH3

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Complaint, Ill-Defined (2331)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Prosthesis failure - event occasionally recorded as a result of an x-ray check in (b)(6) 2018 following a terrible triad.Unanticipated medical procedure.

Event Description

Prosthesis failure - event occasionally recorded as a result of an x-ray check in (b)(6) 2018 following a terrible triad.Unanticipated medical procedure.

Manufacturer Narrative

The reported event that #4 bipolar stem implant (sterile packed) was alleged of 'component loosened' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event (when did the implant loosen, what was the patient's activity level, what are the patient's details must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: #3 BIPOLAR RADIAL HEAD IMPLANT (STERILE PACKED)
• Type of Device: ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7404141
• MDR Text Key: 104659192
• Report Number: 0008031020-2018-00273
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K023604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: RCNH3
• Device Lot Number: 24996901
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR