MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE - 32MM DIA X 2MM THK CONCENTRIC; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 5573-C-3202

Device Problems Material Erosion (1214); Device Damaged by Another Device (2915)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

It was reported that the patient's right reverse shoulder was revised after patient complaint of pain and x-rays showing a peripheral screw loose in the joint.Intra-operatively, it was noted that the peripheral screws had 'windshield wipered' in the joint, etching the glenosphere and passing through the baseplate into the joint.The baseplate, glenosphere and center screw came out all in one piece.

Manufacturer Narrative

The reported event could partially be confirmed, based on the state of the implants returned.The received images revealed that the glenosphere presents two black traces on the metal, caused by the peripheral screws backing out.The joint surface is smooth and does not show any major scratches or deformations.More detailed information about the complaint event such as the x-rays must be available in order to determine the root cause of the complaint event.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 investigation report will be updated.

Event Description

It was reported that the patient's right reverse shoulder was revised after patient complaint of pain and x-rays showing a peripheral screw loose in the joint.Intra-operatively, it was noted that the peripheral screws had 'windshield wipered' in the joint, etching the glenosphere and passing through the baseplate into the joint.The baseplate, glenosphere and center screw came out all in one piece.

• Brand Name: GLENOSPHERE - 32MM DIA X 2MM THK CONCENTRIC
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10864580
• MDR Text Key: 217093083
• Report Number: 0008031020-2020-02483
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098877
• UDI-Public: 07613327098877
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Model Number: 5573-C-3202
• Device Catalogue Number: 5573-C-3202
• Device Lot Number: 738122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR