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

Model Number	5573-C-3602
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the patient arrived in dr's office for a post-op follow-up visit with left shoulder pain.Upon reviewing the x-ray it was evident the glenosphere had dissociated requiring a revision procedure.".
Event or Problem Description
As reported: "the patient arrived in dr's office for a post-op follow-up visit with left shoulder pain.Upon reviewing the x-ray it was evident the glenosphere had dissociated requiring a revision procedure.".
Additional Manufacturer Narrative
The reported event could be confirmed, since x-rays were provided and they show that the implant dislocated.The device was returned and inspected.Some deformation can be noticed on the surface of the glenosphere, probably during impaction on the implantation phase.However, no deformation that could have prevented the implant for functioning properly can be noted.The polyethelyne of the humeral insert shows some serious deformation on one side.The pe is crushed and highly deformed, which proved that a lot of loading was applied on one side of the implant, and not on its center.This could be due to an improper alignment of the implants on the scapular side and those on the humeral side.Since an x-ray was provided, the opinion of a medical expert was request.The statement is as follows: " [.] this is pretty hard to assess with the given information, but the most probable scenarios are the following: either there has been an extraordinary impact on a correct implanted prosthesis or the prosthesis was not implanted properly and produced loads that led to the dissociation of the inlay from baseplate.As the patient does not report such an extraordinary event and the activity level is moderate, the most likely possibility is, that the implant was implanted either too loose with too much play between the glenoid and the humeral component or that either the glenoid or the humeral component were rotationally advantageous implanted.In the one x-ray it looks as if the humeral component could possibly be orientated posteriorly.The glenosphere inlay also has some damage at its rim.That could also be the result of a conflict with the stem.If there is contact not only between the head and the inlay but also between the stem and the inlay, the stem could work as a lever arm which applies a force two both the inlay and the connection between the baseplate and the inlay leading to a dislocation of the inlay as a result.However, this can only be denied or confirmed if more information is provided from the customer¿s side.[.]" based on investigation, the root cause could not be determined since not enough information is available.Pre-operative x-rays are required to assess this case more in details.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 complaint report will be updated.

• Brand Name: GLENOSPHERE - 36MM DIA X 2MM THK CONCENTRIC
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11600204
• Report Number: 0008031020-2021-00116
• Device Sequence Number: 14566668
• Product Code: KWS
• UDI-Device Identifier: 07613327098884
• UDI-Public: 07613327098884
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/30/2025
• Device Model Number: 5573-C-3602
• Device Catalogue Number: 5573-C-3602
• Device Lot Number: M138YD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 06/24/2021
• 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: 60 YR
• Patient Weight: 82