MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 36MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5572-4536
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that a stage 1 revision of the patient's left shoulder was performed due to infection.Surgeon reported infection as (b)(6).Patient's entire shoulder construct was removed and a spacer was placed.Rep reported that the hospital and surgeon will not release any further information.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.No additional information such as medical records, x-rays or surgery reports was provided although repeatedly requested due to (¿hospital policy¿).Likewise, no further information regarding the kind of infection was provided.We have received no information regarding other potential sources of infection, including but not limited to the patient or the facility.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.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that a stage 1 revision of the patient's left shoulder was performed due to infection.Surgeon reported infection as mrsa.Patient's entire shoulder construct was removed and a spacer was placed.Rep reported that the hospital and surgeon will not release any further information.

• Brand Name: 4.5MM PERIPHERAL SCREW - 36MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8441674
• Report Number: 0008031020-2019-00289
• Device Sequence Number: 2887827
• Product Code: KWS
• UDI-Device Identifier: 07613327098761
• UDI-Public: 07613327098761
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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 Catalogue Number: 5572-4536
• Device Lot Number: 3L0L2E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/16/2019
• 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: 69 YR
• Patient Weight: 107