MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN ARTIFICIAL SCAPULAR HEAD (STEM); PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_SEL

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

Patient Problem Limb Fracture (4518)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported: "simplex was used for the operation of the artificial scapular head.Cement was inserted into a cement gun using a humeral nozzle, but it hardened in about 3 minutes.Because hardening was quick at the time of inserting the stem, the surgeon hit it with a hammer and inserted it, and then the patient¿s bone broke.The cement was delivered to the operation room from central (b)(4) medical link on july 22 and kept refrigerated until the day of the operation.I took it out of the refrigerator 5-10 minutes before using the cement.The chief of the operating room requested that the cement was cured quickly and that there was no problem with the product.".

• Brand Name: UNKNOWN ARTIFICIAL SCAPULAR HEAD (STEM)
• 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: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10586767
• MDR Text Key: 208546354
• Report Number: 0008031020-2020-02272
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2020
• 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
• Patient Outcome(s): Other