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

Catalog Number 5572-4516

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

It was reported that patient's shoulder (side not reported) was revised due to a loose glenoid component and pain.Though the patient denied any trauma prior to revision, surgeon feels trauma was involved.All components except the well-fixed stem were revised.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Event Description

It was reported that patient's shoulder (side not reported) was revised due to a loose glenoid component and pain.Though the patient denied any trauma prior to revision, surgeon feels trauma was involved.All components except the well-fixed stem were revised.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

The reported event that a reunion rfx reversible fracture shoulder system was alleged of loosening could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by trauma after implantation.Even though the patient denied trauma prior to revision, the surgeon¿s expertise assures that trauma was involved, even if it was unconscious.Indeed, the prosthesis system is not intended to withstand mechanical loads as well as natural bone structures.As a reminder, the ifu for the reunion system states, surgeons must caution patients to limit activities, protect the bone from unreasonable stresses, and to follow the instructions of the physician with respect to follow-up care and treatment.Surgeons must warn patients of the surgical risks, and made aware of possible adverse effects.The patient should be warned that the device cannot and will not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged, particularly as a result of strenuous activity or trauma, and that the device has a finite expected service life and may need to be replaced in the future.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 any further information is provided, the complaint report will be updated.

• Brand Name: 4.5MM PERIPHERAL SCREW - 16MM
• Type of Device: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7274945
• MDR Text Key: 100234936
• Report Number: 0008031020-2018-00123
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5572-4516
• Device Lot Number: 807NV3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 88