MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 24MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5572-4524
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Hematoma (1884); Injury (2348)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device retained by the hospital.
Event or Problem Description
It was reported that the patient's left shoulder was revised due to implant loosening.Due to the presence of a hematoma, the surgeon reported that trauma had to be a factor.The patient's entire shoulder construct except for the humeral stem was revised.Rep reported that no further information is available.
Event or Problem Description
It was reported that the patient's left shoulder was revised due to implant loosening.Due to the presence of a hematoma, the surgeon reported that trauma had to be a factor.The patient's entire shoulder construct except for the humeral stem was revised.Rep reported that no further information is available.Additionally reported: the patient had a couple of falling events.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The event description states that the surgeon found the presence of hematomas, following a patient fall.This kind of event is classified as a patient misuse.Indeed, a total joint replacement is not supposed to withstand loads such as the ones caused by a fall or similar events, as pointed out in the "patient information" section of the instructions for use.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: 4.5MM PERIPHERAL SCREW - 24MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9727814
• Report Number: 0008031020-2020-00495
• Device Sequence Number: 19564983
• Product Code: KWS
• UDI-Device Identifier: 07613327098730
• UDI-Public: 07613327098730
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

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: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: 5572-4524
• Device Catalogue Number: 5572-4524
• Device Lot Number: 56734K
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 05/21/2020
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 83