MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 16MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 5572-4516

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Loss of Range of Motion (2032); Osteopenia/ Osteoporosis (2651)

Event Date 01/12/2021

Event Type  Injury  

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 : clinical case - still in patient.

Event Description

Reunion rsa study: subject 02-051.Patient felt a pop 7 weeks post-op and came in.Images showed stress fracture at base of acromion w/o substantial displacement.She does have osteoporosis which may have contributed.Actions taken: sling with limited mobility resolved with sequelae: (b)(6) 2021.

Event Description

Reunion rsa study: subject (b)(6).Patient felt a pop 7 weeks post-op and came in.Images showed stress fracture at base of acromion w/o substantial displacement.She does have osteoporosis which may have contributed.Actions taken: sling with limited mobility resolved with sequelae: (b)(6) 2021.

Manufacturer Narrative

The received x-rays were reviewed by medical affairs and the event of the acromion base fracture can be confirmed on both 6-months postoperative x-rays.A device inspection was not possible since the affected device was not returned.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.The available information was forwarded to medical affairs for review with following feedback: "the event of the acromion base fracture can be confirmed on both 6-months postoperative x-rays.In this case the osteoporosis is a factor that may have contributed to this event." the available information indicates that a patient related factor did contribute to this event.However, more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: 4.5MM PERIPHERAL SCREW - 16MM
• Type of Device: 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: 17258201
• MDR Text Key: 318572904
• Report Number: 0008031020-2023-00262
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098716
• UDI-Public: 07613327098716
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 5572-4516
• Device Catalogue Number: 5572-4516
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 69 KG