MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; STEM, HUMERAL SIZE8 RSP

Model Number 506-00-008

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 06/07/2017

Event Type  Injury  

Event Description

Revision surgery - due to an infected total shoulder.

Manufacturer Narrative

Corrected data: the part and lot number was reported as 506-03-0122, lot 830c1271 should be 506-03-122, lot 832c1271.Manufacturer narrative: the reason for this revision surgery was reported as an infection.The previous surgery and the revision detailed in this investigation occurred 5.8 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 infection or inhibited the patient's immune system.The healthcare professional indicated there was 10 minute 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) 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.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.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.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.

• Brand Name: RSP SHOULDER
• Type of Device: STEM, HUMERAL SIZE8 RSP
• 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: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445
• MDR Report Key: 6694579
• MDR Text Key: 79314217
• Report Number: 1644408-2017-00545
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888912024389
• UDI-Public: (01)00888912024389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: 506-00-008
• Device Catalogue Number: 506-00-008
• Device Lot Number: 814C1191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 07/26/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 415-00-120,LOT 7714394; 506-03-0122,LOT 830C1271; 506-03-118,LOT 832C1275; 506-03-130,LOT 835C1212; 506-03-134,LOT 836C1051; 508-00-000,LOT 848C1948; 508-00-032,LOT 855C1147; 508-32-101,LOT 862C2236; 508-32-104,LOT 866C2151
• Patient Outcome(s): Required Intervention