MAUDE Adverse Event Report: STRYKER GMBH RADIO CAPITELLUM, RECON HEAD, SIZE #3; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Model Number	410-0008
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	03/01/2017
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 revision surgery, in (b)(6) 2017 she presented with severe pain in her elbow and after performing a series of image studies her surgeon confirmed loosening of the revised radial head implant and further diagnosed her with left elbow collateral ligament insufficient.It is further alleged that during the revision surgery on (b)(6) 2017 the surgeon found the radial head to have dislocated/disassociated from the radial stem.Allegedly the radial head component was revised with another stryker radial head implant.
Additional Manufacturer Narrative
Correction: refer to h6 patient code.The reported event that radio capitellum, recon head, size #3 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 revision surgery, in (b)(6) 2017 she presented with severe pain in her elbow and after performing a series of image studies her surgeon confirmed loosening of the revised radial head implant and further diagnosed her with left elbow collateral ligament insufficient.It is further alleged that during the revision surgery on (b)(6) 2017 the surgeon found the radial head to have dislocated/disassociated from the radial stem.Allegedly the radial head component was revised with another stryker radial head implant.

• Brand Name: RADIO CAPITELLUM, RECON HEAD, SIZE #3
• Common Device Name: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9983893
• Report Number: 0008031020-2020-01386
• Device Sequence Number: 4442211
• Product Code: JDB
• UDI-Device Identifier: 00886385026015
• UDI-Public: 00886385026015
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• 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: 09/30/2016
• Device Model Number: 410-0008
• Device Catalogue Number: 4100008
• Device Lot Number: 22767501
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 8031020-10/24/2017-002R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR