MAUDE Adverse Event Report: ENCORE MEDICAL L. P. SHOULDER PRIMARY HUMERAL STEM; HEAD, HUMERAL, NEUTRAL, 42-16

Model Number	520-42-016
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to patient was diagnosed for conversion from hemi shoulder to a reverse shoulder.Removed the humeral head.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery.Was reporte,d as conversion from hemi shoulder to a reverse shoulder.The previous surgery and the surgery detailed in this event occurred (b)(6) year and (b)(6) months apart.The healthcare professional indicated, there was no delay in surgery.And another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at hospital.And not made available to (b)(6) surgical for examination.A review of the device history record (dhr) shows, that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was no non-conforming material reports (ncmr) associated with the product that may have contributed to the reported event.The device was verified, to have gone through an acceptable sterilization process.And was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device showed, no present trends or on-going issues that are needing a review.The root cause of this complaint was reported, as conversion from hemi shoulder to a reverse shoulder.There were no findings, during this evaluation that, indicate the reported device was defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may also contribute to an event that are outside the control of (b)(6) surgical, such as poor bone density, patient bone deterioration, inadequate soft tissue support, patient activities or trauma.There are no indications, of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided, as a supplemental report to this document as soon as it becomes available.

• Brand Name: SHOULDER PRIMARY HUMERAL STEM
• Common Device Name: HEAD, HUMERAL, NEUTRAL, 42-16
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 11114060
• Report Number: 1644408-2020-01288
• Device Sequence Number: 19814027
• Product Code: KWS
• UDI-Device Identifier: 00888912145114
• UDI-Public: (01)00888912145114
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 520-42-016
• Device Catalogue Number: 520-42-016
• Device Lot Number: 909C1072
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 03/12/2021
• 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: 55 YR