MAUDE Adverse Event Report: STRYKER GMBH HUMERAL CUP - 36MM DIA X 4MM THK; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 5570-3604

Device Problem Inaccurate Information (4051)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; hospital retained.

Event Description

As reported; "the non-sterile shoulder insert inside the packaging was not the same implant as what was labeled.The implant box was a 36+4 cup, and inside was what appeared to be a 36+4 insert.There was no backup 36+4 cup, so we could not proceed with putting this in as the final implant.We had to switch to a size 32 for the cup and insert, but ended successfully.There was a surgical delay of about an hour due to taking out the implants to switch to size 32.During a left shoulder case, the rep found that the box for a 36x4 humeral cup (catalog 5570-3604 lot rhhjra) had already been opened.Inside the box was some packaging for competitor gauze, and a ¿dirty¿ shoulder insert.The rep explained that there didn¿t appear to be any bioburden on the insert, that it looked like it might have been dropped on the floor.".

Manufacturer Narrative

Correction: please refer to d4 lot number.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.However, the statement from the rep present in the case stated that the device was already opened when the surgery had started.It is the responsibility of the hospital to check the devices prior to the operation, and to discard all used/ opened implants, as per the instructions of the ifu.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

As reported; "the non-sterile shoulder insert inside the packaging was not the same implant as what was labeled.The implant box was a 36+4 cup, and inside was what appeared to be a 36+4 insert.There was no backup 36+4 cup, so we could not proceed with putting this in as the final implant.We had to switch to a size 32 for the cup and insert, but ended successfully.There was a surgical delay of about an hour due to taking out the implants to switch to size 32.During a left shoulder case, the rep found that the box for a 36x4 humeral cup (catalog 5570-3604 lot rhhjra) had already been opened.Inside the box was some packaging for competitor gauze, and a ¿dirty¿ shoulder insert.The rep explained that there didn¿t appear to be any bioburden on the insert, that it looked like it might have been dropped on the floor.".

• Brand Name: HUMERAL CUP - 36MM DIA X 4MM THK
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12860043
• MDR Text Key: 281145775
• Report Number: 0008031020-2021-00473
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098365
• UDI-Public: 07613327098365
• 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: 03/11/2022

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: 5570-3604
• Device Catalogue Number: 5570-3604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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