MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; RSP HUM SOCKET INSERT 40MM +4MM, STANDARD

Model Number	508-00-440
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery.This was a scheduled two stage revision.During the first surgery the surgeon used a large amount of bone graft in the glenoid, the surgeon thought it was best to leave the glenosphere off so the bone graft could heal.The graft healed and this surgery was to place the glenosphere and replace the insert.
Additional Manufacturer Narrative
The reason for this stage two revision was the surgeon added a new glenosphere and insert.During the first surgery the surgeon used a large amount of bone graft in the glenoid, the surgeon thought it was best to leave the glenosphere off so the bone graft could heal.The graft healed and this stage two surgery was to place the glenosophere and replace the insert.The original glenosphere was in-vivo for 6.4 months.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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.Review of the device history record (dhr) for the explanted part revealed no discrepancies or issues during the manufacture of this part.The dhr evidences that all critical dimensions, design criteria and specifications in effect at the time the part was manufactured were met.The complaint investigation history was reviewed and no trends or on-going issues were deemed as present or in need of review.No issues or anomalies were observed with the concomitant part.No further action is deemed necessary at this time.This event is deemed as non-product related.The root cause for this event was the surgeon added a bone graft in the patient's joint and later, when healed, the surgeon added a new glenosphere and insert.The surgeon reported no issues associated with the explanted product.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions, root cause, relating to this event could not be determined with confidence.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP SHOULDER
• Common Device Name: RSP HUM SOCKET INSERT 40MM +4MM, STANDARD
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6725373
• Report Number: 1644408-2017-00576
• Device Sequence Number: 1236651
• Product Code: KWS
• UDI-Device Identifier: 00888912144223
• UDI-Public: (01)00888912144223
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K100741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2017

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: 07/31/2018
• Device Model Number: 508-00-440
• Device Catalogue Number: 508-00-440
• Device Lot Number: 920F1023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 09/01/2017
• 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