MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE - 40MM DIA X 2MM THK CONCENTRIC; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 5573-C-4002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Metal Related Pathology (4530)

Event Date 10/06/2022

Event Type  Injury  

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

It was reported that a patient underwent had their shoulder stem removed 6 weeks post opp due to metallosis.

Manufacturer Narrative

The reported event could not be confirmed.The device inspection revealed the following: the identification of the glenosphere - 40mm dia x 2mm thk concentric could be confirmed based on the catalog # and the lot # marked.The implant looks relatively new with only small scratches and wear marks due to normal usage.It was not possible to determine if metallic particles were created.It was not possible to confirm the reported metallosis, as not enough information was provided in this case.Furthermore, as indicated by medical experts, "metallosis is about the type-iv immune response to the accumulation of metal particles within tissues.There are cases of early arthroplasty failure due to metallosis, yet these patients usually do well initially and start to get pain and joint stiffness after months, leading to revision within 2 years.".However, the reported metallosis was observed after 6 weeks of implantation, a post-surgical lapse of time much shorter than what is usually observed for such response.This gives further indication of the lack of evidence pointing towards metallosis and the impossibility to confirm the reported event.Based on the investigation, no problem could be detected on the glenosphere and the link with a possible metallosis could not be established.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 more information is provided, the case will be reassessed.

Event Description

It was reported that a patient underwent had their shoulder stem removed 6 weeks post opp due to metallosis.

• Brand Name: GLENOSPHERE - 40MM 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15886724
• MDR Text Key: 304530946
• Report Number: 0008031020-2022-00665
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098945
• UDI-Public: 07613327098945
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5573-C-4002
• Device Catalogue Number: 5573-C-4002
• Device Lot Number: EH47T5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention