MAUDE Adverse Event Report: STRYKER GMBH 6.5MM CENTER SCREW - 28M M; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 5573-6528

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

Patient Problems Hemorrhage/Bleeding (1888); Post Operative Wound Infection (2446)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.

Event Description

As reported: "patient experienced excess drainage from incision site on (b)(6) 2020 that persisted over 2 days.Patient started taking cephalexin 250 mg 4x/day on (b)(6) 2020.Patient reported improvement on (b)(6) 2020.Patient will continue to take medication for two weeks and will follow-up for wound check.(b)(6) 2020: incision began bleeding again on (b)(6) 2020.Patient seen on (b)(6) 2020, labs ordered on (b)(6) 2020.Due to excess drainage, plan will be revision surgery.".

Event Description

As reported: "patient experienced excess drainage from incision site on (b)(6) 2020 that persisted over 2 days.Patient started taking cephalexin 250 mg 4x/day on (b)(6) 2020.Patient reported improvement on (b)(6) 2020.Patient will continue to take medication for two weeks and will follow-up for wound check.(b)(6) 2020: incision began bleeding again on (b)(6) 2020.Patient seen on (b)(6) 2020, labs ordered on (b)(6) 2020.Due to excess drainage, plan will be revision surgery.".

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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, drainage from the incision site could be more attributable to the user related (improper wound closure) or predominantly patient factor (premedical condition, failure to follow postoperative behavioral requirements or improper wound healing etc.).If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: 6.5MM CENTER SCREW - 28M M
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10931109
• MDR Text Key: 219137595
• Report Number: 0008031020-2020-02543
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098822
• UDI-Public: 07613327098822
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5573-6528
• Device Catalogue Number: 5573-6528
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 96