MAUDE Adverse Event Report: STRYKER GMBH BASEPLATE; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 5572-2800

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

We were revising a reverse total shoulder.The baseplate with the glenosphere came out all together.There was no ingrowth on the baseplate.The patient had no infection.The surgeon had to covert him to a hemi arthroplasty as there was no bone left around the glenoid.

Manufacturer Narrative

The reported event 5572-2800 ¿ baseplate alleged that ¿the baseplate with the glenosphere came out altogether.There was no ingrowth on the baseplate." could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Provided x-ray image showed the implanted devices and was dated 09/27/2017 presenting a follow-up.Provided image did not identify a product matter.The affected device appeared being intact on the image.The event description already identified missing ingrowth on the baseplate which is considered being patient related.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 labelling 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.With available information a product deficiency was not verified.

Event Description

We were revising a reverse total shoulder.The baseplate with the glenosphere came out all together.There was no ingrowth on the baseplate.The patient had no infection.The surgeon had to covert him to a hemi arthroplasty as there was no bone left around the glenoid.

• Brand Name: BASEPLATE
• 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: 7371332
• MDR Text Key: 103486443
• Report Number: 0008031020-2018-00214
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 7613327098709
• UDI-Public: (01)7613327098709
• Combination Product (y/n): N
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 5572-2800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR