MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN RSA REUNION PERIPHERAL SCREW; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_SEL

Device Problems Device Appears to Trigger Rejection (1524); Naturally Worn (2988)

Patient Problems Unspecified Infection (1930); Loss of Range of Motion (2032); Metal Related Pathology (4530); Implant Pain (4561)

Event Date 01/28/2022

Event Type  Injury  

Event Description

As reported; "surgeon had a patient come in 2 weeks ago that had a reverse total shoulder reunion done at a different facility.The patient presented with shoulder stiffness and a lot of pain.X-rays showed aseptic loosening and surgeon suspected deep infection.During the surgery the surgeon noticed extreme metallosis on the glenoid side of the implant and he cleaned it all out by hand without instrumentation where the 2 peripheral screws stayed inside the glenoid and did not come out of the baseplate.Took all the implants out.After the case, upon close inspection of the glenoid baseplate he noticed that the peripheral screws where they lock into the baseplate through the threads had worn away due to aseptic loosening and infection.This had worn all the way through and the screws had pulled all the way through the baseplate.All implants were removed from the shoulder and a cement antibiotic spacer was put in.Surgeon reported that the patient is very happy with the outcomes.Implants were discarded by the hospital.No additional information is available.".

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

• Brand Name: UNKNOWN RSA REUNION PERIPHERAL SCREW
• 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: 13656568
• MDR Text Key: 287344666
• Report Number: 0008031020-2022-00082
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male