MAUDE Adverse Event Report: STRYKER GMBH HUMERAL CUP - 36MM DIA X 4MM THK; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 5570-3604

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

Patient Problems Bone Fracture(s) (1870); Implant Pain (4561)

Event Date 11/24/2021

Event Type  Injury  

Event Description

As reported: "acromial stress fracture non-union.Patient experiencing pain over proximal and distal locking bolt sites.Reoperation to remove locking bolts".

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.\.

Manufacturer Narrative

The reported event could be confirmed based on the x-rays received for investigation.The inspection of the pictures revealed the following: the post-operative x-rays confirmed the reported pain due to acromial stress fracture occurring 6 months after implantation.However, it was not possible to determine the specific cause of the post-operative fracture.To determine a root cause in this case, more clinical information is needed.Medical experts have indicated that: " the incidence of acromial stress fractures in reversed shoulder arthroplasty is relatively rare but has been reported in a small number of case studies and case series.Preventative measures include careful patient selection, appropriate implant positioning, and postoperative rehabilitation to prevent overuse of the affected shoulder.Acromial stress fractures in reversed shoulder arthroplasty can be caused by several factors, including: 1.High levels of stress on the acromion due to abnormal biomechanics caused by the reversed shoulder implant.2.Pre-existing osteoporosis or other bone conditions that make the acromion more susceptible to fractures.3.High activity levels or repetitive overhead motions that increase stress on the acromion.4.Postoperative infection or inflammation that can lead to increased stress on the acromion.5.Surgical technique and implant design, that may cause increased stress on the acromion.It is important to note that these are not the only possible causes of acromial stress fractures, and further evaluation by a medical professional is necessary to determine the specific cause of the fracture." based on the investigation, it was not possible to determine the root cause of the reported event.Several factors may lead to an acromial stress fracture and in order to determine the specific cause in this case, more clinical information is needed.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.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.

Event Description

As reported: "acromial stress fracture non-union.Patient experiencing pain over proximal and distal locking bolt sites.Reoperation to remove locking bolts".

• Brand Name: HUMERAL CUP - 36MM DIA X 4MM THK
• 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: 15864072
• MDR Text Key: 304286085
• Report Number: 0008031020-2022-00642
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098365
• UDI-Public: 07613327098365
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5570-3604
• Device Catalogue Number: 5570-3604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2023
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 84 KG