MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; RSP BASEPLATE, 30MM, W/P2 COATING

Model Number 508-32-204

Device Problem Component Falling (1105)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 05/16/2017

Event Type  Injury  

Event Description

Revision surgery - due to the patient falling and breaking their scapula.The surgeon turned the current reverse into a hemi.

Manufacturer Narrative

The reason for this revision surgery was the patient's scapula broke.The in-vivo length of patient service for the implant was 1.2 months.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 (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions, design criteria and specifications in effect at the time the part was manufactured were met.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed as non-product related.The root cause for this event was the patient had fallen and broke the scapula.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP SHOULDER
• Type of Device: RSP BASEPLATE, 30MM, W/P2 COATING
• 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: 6644487
• MDR Text Key: 77663565
• Report Number: 1644408-2017-00453
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888912144391
• UDI-Public: (01)00888912144391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112069
• 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: 07/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2022
• Device Model Number: 508-32-204
• Device Catalogue Number: 508-32-204
• Device Lot Number: 769P1158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2017
• 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: 506-03-114,LOT 831C1379; 506-03-114,LOT 831C1379; 506-03-114,LOT 831C1387; 506-03-122,LOT 833C1289; 508-32-103,LOT 864C2557; 509-01-432,LOT 389P1034
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR