MAUDE Adverse Event Report: STRYKER GMBH BASEPLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5572-2800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
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.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.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, most probable root cause could be but not limited to patient factor (active or suspected latent infection) or user related (e.G., compromised sterile environment condition during surgery) etc.If device is returned or any further information is provided, the investigation report will be reassessed.Device is not available; device remains implanted in patient.
Event or Problem Description
As reported: "intra-op cultures came back positive for p.Acnes.No gross purulence noted during surgery.Patient started taking amoxicillin on (b)(6) 2020.Continued follow-up scheduled with infectious disease clinic to monitor.".
Additional Manufacturer Narrative
Correction: refer to h6 method code.
Event or Problem Description
As reported: "intra-op cultures came back positive for(b)(6) no gross purulence noted during surgery.Patient started taking amoxicillin on (b)(6) 2020.Continued follow-up scheduled with infectious disease clinic to monitor.".

• Brand Name: BASEPLATE
• 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: 11136149
• Report Number: 0008031020-2021-00011
• Device Sequence Number: 11686931
• Product Code: KWS
• UDI-Device Identifier: 07613327098709
• UDI-Public: 07613327098709
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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 Expiration Date: 09/01/2024
• Device Model Number: 5572-2800
• Device Catalogue Number: 5572-2800
• Device Lot Number: K57K8A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 01/13/2021
• 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: 66 YR
• Patient Weight: 101