MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ENCORE SHOULDER; TURON PRIMARY HUMERAL STEM, SZ 12

Model Number	520-01-012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to subscap failure, removed all components and installed djo reverse shoulder.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as sub- cup failure.The previous surgery and the surgery detailed in this event occurred 10.9 years apart.The healthcare professional indicated there was a significant adverse event to the patient.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.This investigation is limited in scope as only partial information was provided to djo surgical for review.The revised items were not returned for examination and the lot numbers were not provided.Given the limited information, a search for an invoice (of the previous surgery) produced no results, therefore; the items removed could not be identified.To adequately investigate this event, the lot numbers are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Additional Manufacturer Narrative
Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: ENCORE SHOULDER
• Common Device Name: TURON PRIMARY HUMERAL STEM, SZ 12
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 15510442
• Report Number: 1644408-2022-01278
• Device Sequence Number: 6041160
• Product Code: KWS
• UDI-Device Identifier: 00888912024907
• UDI-Public: (01)00888912024907
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

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: 10/13/2011
• Device Model Number: 520-01-012
• Device Catalogue Number: 520-01-012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 520-00-000 LOT UNKNOWN; 520-46-016 LOT UNKNOWN; 521-01-246 LOT UNKNOWN
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female