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

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

Primary procedure, right reverse shoulder.It was reported that upon opening the glenosphere, the impactor would not insert into the implant due to foreign matter in the screw hole of the implant.A second implant of a different size was available and used instead to complete the surgery successfully with a delay of approximately 3-4 minutes.

Manufacturer Narrative

Correction: refer to d9/h3 device availability.The reported event could be confirmed.It could be confirmed that the debris reported in the complaint was a plug used to protect the threads of the glenosphere during the polishing phase of the device during manufacturing.The plug was not taken out during production and stayed into the device, and was observed by the end customer during surgery.A corrective action report has been opened in order to further investigate and address this issue for further details.A review of the device history for the reported lot did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

Event Description

Primary procedure, right reverse shoulder.It was reported that upon opening the glenosphere, the impactor would not insert into the implant due to foreign matter in the screw hole of the implant.A second implant of a different size was available and used instead to complete the surgery successfully with a delay of approximately 3-4 minutes.

• Brand Name: GLENOSPHERE - 36MM 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 ; CH 2545
• MDR Report Key: 10026911
• MDR Text Key: 193613778
• Report Number: 0008031020-2020-01424
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098884
• UDI-Public: 07613327098884
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5573-C-3602
• Device Catalogue Number: 5573-C-3602
• Device Lot Number: 952YT7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR