MAUDE Adverse Event Report: STRYKER GMBH PRESS-FIT HUMERAL STEM 13MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5567-P-3013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteopenia/ Osteoporosis (2651); Limb Fracture (4518)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition is unknown.
Event or Problem Description
As reported: "intraoperative fracture of the humerus.Event was resolved without sequelae (without additional medical intervention).".
Event or Problem Description
As reported: "intraoperative fracture of the humerus.Event was resolved without sequelae (without additional medical intervention).".
Additional Manufacturer Narrative
Please note corrections to sections b2 and h6 (method, results, and conclusion codes).The reported event could be confirmed based on the x-rays inspected.The device was not returned for inspection.However, post-operative x-rays were received.The reported event could be confirmed as the humeral fracture is clearly visible.The x-rays received give indication of osteopenic bone, which could be a direct cause of the humeral fracture.Although medical error and forced fracture during the implantation could not be excluded, this could not be confirmed either since it was not possible to determine exactly when during the procedure the bone was fractured.The images received were reviewed by a medical expert, who stated: "the x-rays show a reunion reverse total shoulder arthroplasty which is positioned well.The x-rays may give the impression that the bone is osteopenic, however this are not medical grade images.The x-ray shows a fracture fragment that is a part of the greater tuberosity.I cannot assess when in the procedure this avulsion happened, it may have been (1) avulsed during humeral head dislocation, or (2) pre-damaged by the humeral head resection, or later in the procedure during (3) opening of the medullary canal or even (4) with the broaches.Obviously, in (1) and (2) neither instrument nor the device are involved.(3) and (4) would be most likely surgical technique related.Above all, the alleged poor bone quality related to all 4 phases described above.Please note that avulsion also may have happened while reducing the joint with the final implant in place, since there is a fair amount of humeral distalization in this case with the use of a thick tray." based on investigation, the root cause was attributed to a bone condition related issue.The osteopenia observed on the patient's bone could be identified as a cause of the fracture.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: PRESS-FIT HUMERAL STEM 13MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18387030
• Report Number: 0008031020-2023-00440
• Device Sequence Number: 14112054
• Product Code: KWS
• UDI-Device Identifier: 07613327424973
• UDI-Public: 07613327424973
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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 Catalogue Number: 5567-P-3013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 95 KG