MAUDE Adverse Event Report: STRYKER GMBH PRESS-FIT HUMERAL STEM 14MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5567-P-3014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Post Operative Wound Infection (2446)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem 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.".
Additional 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.
Event or Problem 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.11/2/2020: 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.".

• Brand Name: PRESS-FIT HUMERAL STEM 14MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10931086
• Report Number: 0008031020-2020-02537
• Device Sequence Number: 2757953
• Product Code: KWS
• UDI-Device Identifier: 07613327424812
• UDI-Public: 07613327424812
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K183039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 5567-P-3014
• Device Catalogue Number: 5567-P-3014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 96