MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL

Model Number 508-36-101

Device Problem Insufficient Information (3190)

Patient Problems Loss of Range of Motion (2032); Obstruction/Occlusion (2422)

Event Date 08/08/2018

Event Type  Injury  

Event Description

Revision surgery - due to the patient having a lack of range of motion due to an obstruction.

Manufacturer Narrative

Corrected data: see implant date.Initially reported (b)(6) 2016, but corrected to (b)(6) 2016.Manufacturer narrative: the reason for this revision surgery was due to shoulder stiffness (lack of range of motion).The previous surgery and the revision detailed in this investigation occurred over 1 year 9 months apart.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.A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There was a non-conforming material reports (ncmrs) associated with the part# 508-36-101, glenoid head with retaining screw, rsp (reverse shoulder prosthesis), 36 millimeter, neutral which documents a non-conformance that out of a 15 quantity lot, 4 item were rejected due to out of tolerance condition.Rejected items were reworked with suitable operations and were accepted.All items in the lot met the design, fit and function requirements.The device was within its respective expiration dates at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to shoulder stiffness (lack of range of motion).There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.There are multiple factors that may contribute to the event that are outside the control of djo surgical such as: patient activities, pre-operative restricted motion, ligament tear, joint swelling, insufficient physical therapy post-surgery or trauma.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

Manufacturer Narrative

Corrected data: corrected concomitant lot number.

• Brand Name: RSP SHOULDER
• Type of Device: GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7778400
• MDR Text Key: 116946430
• Report Number: 1644408-2018-00778
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024761
• UDI-Public: (01)00888912024761
• Combination Product (y/n): N
• PMA/PMN Number: K051075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2022
• Device Model Number: 508-36-101
• Device Catalogue Number: 508-36-101
• Device Lot Number: 869C2113
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 508-00-036, LOT 856C1918; 508-00-036, LOT 866C1918; 510-08-000, LOT 142G1140; 510-08-000, LOT 142G1140; 508-00-036, LOT 866C1918; 510-08-000, LOT 142G1140
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR