MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 55MM DISTAL HUMERAL ASSEMBLY KIT; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	6487-H-055
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
It was reported that the patient's left humerus was revised due to the custom humeral adaptor disengaging from the distal portion of the modular elbow humeral assembly.Intra-operatively, the surgeon stated that he believes the devices may not have been fully locked in the primary procedure.The surgeon disengaged the devices, locked them fully, and re-engaged the in situ devices.As a screw had been removed, the surgeon implanted new screws.Rep provided the primary usage sheet, confirmed there was no allegation against the revised screw, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: 55MM DISTAL HUMERAL ASSEMBLY KIT
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10710007
• Report Number: 0002249697-2020-02198
• Device Sequence Number: 14217652
• Product Code: HSD
• UDI-Device Identifier: 07613327139303
• UDI-Public: 07613327139303
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: D047155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2020

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 Expiration Date: 03/31/2024
• Device Model Number: 6487-H-055
• Device Catalogue Number: 6487-H-055
• Device Lot Number: TAGX503A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/21/2020
• 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
• Patient Age: 56 YR