MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN REUNION CENTRAL SCREW; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_SEL

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 02/27/2024

Event Type  Injury  

Event Description

As reported: a revision surgery was performed on (b)(6) 2024 using the blueprint planning feature.The primary implants were the stryker reunion system.The patient needed a revision surgery because the baseplate failed (baseplate was loose and it migrated superior) and the center screw was broken.".

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 unknown.

Event Description

As reported: a revision surgery was performed on (b)(6) 2024 using the blueprint planning feature.The primary implants were the stryker reunion system.The patient needed a revision surgery because the baseplate failed (baseplate was loose and it migrated superior) and the center screw was broken.".

Manufacturer Narrative

Please note correction to h6 (results code).The reported event could be confirmed from the available radiograph.With the available image of radiograph, a formal medical opinion was sought:- in the available image of the radiograph, the breakage of the central screw is readily visible which confirms the event of screw breakage and most likely causing the loosening of the glenoid baseplate.The available image is a photograph from a computer monitor, thus not medical-grade imaging.Unfortunately, that limits the level of granularity of the assessment.With the available image determining the root cause is not feasible, for detailed assessment, we would require an x-ray in another direction, a timeline of the event concerning the primary surgery, surgical reports, and the medical information on the patient.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the 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: UNKNOWN REUNION CENTRAL SCREW
• 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 GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19110956
• MDR Text Key: 340234165
• Report Number: 0008031020-2024-00170
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/15/2024
• 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 Sex: Male