MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TURON SHOULDER; TURON PEGGED GLENOID, SZ 38MM, EPLUS

Model Number	521-01-238
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as component loosening.The previous surgery and the surgery detailed in this event occurred 4 years and 7 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 the hospital and not made available to djo surgical for examination.A review of the device history records show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was a ncmr#23835 associated with the concomitant part #520-42-116, head, humeral, offset, 42-16, which documents that out of 10 parts lot, 1 part was rejected due to scratches on finished surface.Later the rejected part was reworked and accepted.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to loosening.There were no findings during this evaluation that indicate that the reported devices were defective.There are multiple factors that may contribute to an event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, excessive range of motion, prolonged overhead activities, patient activities or trauma.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - due to loosening glenoid.

• Brand Name: TURON SHOULDER
• Common Device Name: TURON PEGGED GLENOID, SZ 38MM, EPLUS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 9405180
• Report Number: 1644408-2019-01231
• Device Sequence Number: 11571128
• Product Code: KWS
• UDI-Device Identifier: 00888912025096
• UDI-Public: (01)00888912025096
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K123982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 521-01-238
• Device Catalogue Number: 521-01-238
• Device Lot Number: 798N1011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 12/03/2019
• 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: 63 YR