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

Model Number	RCN-S3
Medical Device Problem Codes	Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Injury (2348)
Date of Event	02/04/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device disposition is unknown.
Event or Problem Description
It was reported by the patient's attorney that allegedly following her replacement surgery the patient began to experience increasing pain and decreased function in her elbow and her surgeon confirmed loosening of the radial head prosthesis.It is further alleged that during the revision surgery on (b)(6) 2015 the surgeon found the radial head component to have dislocated/disassociated from the radial stem.Allegedly the radial head component was revised with another stryker radial head component.
Additional Manufacturer Narrative
The reported event that #3 bipolar stem implant (sterile packed) was alleged of 'implant - dislocated' 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 such as x-rays, patient details, patient activity levels.As well as the affected device 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 or manufacturing problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported by the patient's attorney that allegedly following her replacement surgery the patient began to experience increasing pain and decreased function in her elbow and her surgeon confirmed loosening of the radial head prosthesis.It is further alleged that during the revision surgery on (b)(6) 2015 the surgeon found the radial head component to have dislocated/disassociated from the radial stem.Allegedly the radial head component was revised with another stryker radial head component.

• Brand Name: #3 BIPOLAR STEM IMPLANT (STERILE PACKED)
• Common Device Name: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9981155
• Report Number: 0008031020-2020-01382
• Device Sequence Number: 4356243
• Product Code: KWI
• UDI-Device Identifier: 00886385025162
• UDI-Public: 00886385025162
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K023604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: RCN-S3
• Device Catalogue Number: RCNS3
• Device Lot Number: 21534701
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 06/16/2020
• 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: Required Intervention
• Patient Age: 30 YR