MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION TOTAL SHOULDER; STEM, HUMERAL, PLASMA W/MALE TAPER, 10

Model Number	503-00-010
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as pain.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.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 devices were disposed of at hospital and not made available to djo surgical for examination.To investigate this event, the lot numbers are necessary.In addition to the lot numbers not being supplied, information regarding cultures identified in the infection and the severity of the infection was not supplied.If this information is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.This complaint will be closed pending receipt of additional information.
Event or Problem Description
Revision surgery - patient complained of pain in shoulder - surgeon inspected for infection then converted to a reverse shoulder.

• Brand Name: FOUNDATION TOTAL SHOULDER
• Common Device Name: STEM, HUMERAL, PLASMA W/MALE TAPER, 10
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• MDR Report Key: 9963682
• Report Number: 1644408-2020-00308
• Device Sequence Number: 2857690
• Product Code: KWS
• UDI-Device Identifier: 00888912024334
• UDI-Public: (01)00888912024334
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K950651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2020

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 Model Number: 503-00-010
• Device Catalogue Number: 503-00-010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/15/2020
• 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: 60 YR