MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE - 36MM DIA X 2MM THK 2MM ECCENTRIC; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 5573-2E-3602

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Pain (1994)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.

Event Description

It was reported that patient's right shoulder was revised after patient suffered several falls and complained of pain.The glenoid baseplate was found to have loosened.Surgeon decided to use bone allograft in the glenoid and a humeral head on the existing stem.

Manufacturer Narrative

The reported event that glenosphere - 36mm dia x 2mm thk 2mm eccentric was alleged of 'implant - dislocated' could be confirmed.Based on investigation, the root cause was attributed to be patient related.The failure was caused by as it was reported that the patient suffered several falls.The device inspection revealed the following: some damages and deformations are clearly visible on the returned implants.The close up views (done by the microscope) showing the deformations of the screw holes in the baseplate, which clearly indicate that the force during the patient falls must have been immense.Which resulted in the dislocation of the 3 returned screws.It is also quit evident that the glenosphere is badly worn, which indicates, as the patient had several falls, that the implant positioning afterwards was not correct anymore.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.Note that we are still waiting for a statement of our medical expert.If any further information is provided which differ from the current determination, the investigation report will be updated.

Event Description

It was reported that patient's right shoulder was revised after patient suffered several falls and complained of pain.The glenoid baseplate was found to have loosened.Surgeon decided to use bone allograft in the glenoid and a humeral head on the existing stem.

• Brand Name: GLENOSPHERE - 36MM DIA X 2MM THK 2MM ECCENTRIC
• 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: 7848582
• MDR Text Key: 119323476
• Report Number: 0008031020-2018-00580
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098914
• UDI-Public: 07613327098914
• 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: 12/20/2018

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 Expiration Date: 06/24/2020
• Device Catalogue Number: 5573-2E-3602
• Device Lot Number: NA5YTY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 11/22/2018
• Supplement Dates FDA Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 118