MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. TURON SHOULDER; TURON PRIMARY HUMERAL STEM, SZ 10

Model Number	520-01-010
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/05/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - there was no product issue.The parts reported on this report were used as a temporary spacer while the patient was treated for an infection which was found during the original surgery on (b)(6) 2016.
Additional Manufacturer Narrative
The reason for this revision surgery was an infection.The previous surgery and the revision detailed in this investigation occurred over 6.8 months apart.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 possible infection or inhibited the patient's immune system.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 the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhrs) and product complaint report (pcr) database records show that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to an infection.The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery.There were no findings during this investigation that indicate that the reported device was the root cause or had a direct connection with the patient's infection.It was reported, "there was no product issue.The items were used as a temporary spacer while the patient was treated for an infection." there are multiple factors that may contribute to an infection that are outside of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.
Additional Manufacturer Narrative
D10: adding concomitant part 402439.

• Brand Name: TURON SHOULDER
• Common Device Name: TURON PRIMARY HUMERAL STEM, SZ 10
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 6076682
• Report Number: 1644408-2016-00835
• Device Sequence Number: 11002469
• Product Code: KWS
• UDI-Device Identifier: 00888912024891
• UDI-Public: (01)00888912024891
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2022

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: 10/28/2021
• Device Model Number: 520-01-010
• Device Catalogue Number: 520-01-010
• Device Lot Number: 455G1181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/05/2016
• Supplement Date Received by Manufacturer: Not provided; 11/14/2016
• Initial Report FDA Received Date: 11/03/2016
• Supplement Report FDA Received Date: 12/13/2016; 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2015
• 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: 402439 COBALT-G MV BONE CEMENT 40GM B; 520-00-000, LOT 878C1538; 520-46-020, LOT 919C1042A; 520-00-000, LOT 878C1538; 520-46-020, LOT 919C1042A
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male