MAUDE Adverse Event Report: STRYKER GMBH HUMERAL CUP 36MM DIA X 2MM THK; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number 5570-3602

Device Problems Residue After Decontamination (2325); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

Event Type  malfunction  

Event Description

It was reported that when the humeral cup was opened, it was observed that there was glue adhered to the metal of the implant.The scrub tech pulled it out with an instrument and placed it in the impaction block.The surgeon scraped the material off using a small osteotome but ended up breaking scrub and then using a new implant to complete the surgery.Surgery was completed successfully with a delay of approximately 20 minutes.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event 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 as well as the affected device 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 the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that when the humeral cup was opened, it was observed that there was glue adhered to the metal of the implant.The scrub tech pulled it out with an instrument and placed it in the impaction block.The surgeon scraped the material off using a small osteotome but ended up breaking scrub and then using a new implant to complete the surgery.Surgery was completed successfully with a delay of approximately 20 minutes.

• Brand Name: HUMERAL CUP 36MM DIA X 2MM THK
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14193725
• MDR Text Key: 290804935
• Report Number: 0008031020-2022-00195
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07613327516258
• UDI-Public: 07613327516258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5570-3602
• Device Catalogue Number: 5570-3602
• Device Lot Number: 8657DV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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