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
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7848582
• Report Number: 0008031020-2018-00580
• Device Sequence Number: 16478188
• Product Code: KWS
• UDI-Device Identifier: 07613327098914
• UDI-Public: 07613327098914
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 118