MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE - 36MM DIA X 6MM THK 2MM ECCENTRIC; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5573-2E-3606
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
Patient says that people in the nursing home might have caused his problem by pulling him up under his arm.The glenosphere had disassociated from the baseplate, causing him pain and discomfort.This had been out of place for awhile.He had a fair amount of metallosis in the joint.Because of wear on the baseplate, everything had to be changed to new components except for the stem which was found to be intact and not loose.This was the patient's right shoulder.
Event or Problem Description
Patient says that people in the nursing home might have caused his problem by pulling him up under his arm.The glenosphere had disassociated from the baseplate, causing him pain and discomfort.This had been out of place for awhile.He had a fair amount of metalosis in the joint.Because of wear on the baseplate, everything had to be changed to new components except for the stem which was found to be intact and not loose.This was the patients right shoulder.
Additional Manufacturer Narrative
The reported event that glenosphere - 36mm dia x 6mm thk 2mm eccentric was alleged of 'implant revision/removal without implant breakage' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The reported event that baseplate was alleged of 'implant revision/removal without implant breakage' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event such as pre-operative and post-operative x-rays, as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the complaint event, the most probable root cause could be the reported pull up of the patient by the nursing home staff under his arm.Indeed, this could have caused the different parts of the prosthesis to disassemble.As a reminder, the ifu clearly states: "contraindications patients whose anticipated activities would impose high stresses on the prosthesis and its fixation.As well as: "6 adverse effects dislocation of the shoulder prosthesis can occur due to inappropriate patient activity, trauma or other biomechanical considerations.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: GLENOSPHERE - 36MM DIA X 6MM 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: 7933764
• Report Number: 0008031020-2018-00763
• Device Sequence Number: 10998088
• Product Code: KWS
• UDI-Device Identifier: 07613327098907
• UDI-Public: 07613327098907
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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: 06/30/2022
• Device Catalogue Number: 5573-2E-3606
• Device Lot Number: 3M4M4L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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: 82 YR
• Patient Weight: 104