MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. RSP SHOULDER; RSP GLENOID HEAD W/RETAINING SCREW / -4MM OFFSET 32MM

Catalog Number 508-32-103

Device Problem Human-Device Interface Problem (2949)

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

Event Date 03/03/2014

Event Type  Injury  

Event Description

Revision surgery - the patient fell on the ice after release from the hospital and broke their scapula and glenoid.The surgeon revised from a reverse shoulder prosthesis to a monoblock hemi.

Manufacturer Narrative

Device lost, disposed of.

Manufacturer Narrative

The reason for this revision surgery was due to truama, a broken scapula and glenoid, after 21 days of patient use.The healthcare professional indicated a significant adverse event to the patient.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 showed no non-conforming material reports associated with this product.A review of the product complaint report history showed this is the first complaint for this lot.The root cause of the trauma was reported as a fall.There is no information reported that showed a material, design, or manufacturing problem with the product.

• Brand Name: RSP SHOULDER
• Type of Device: RSP GLENOID HEAD W/RETAINING SCREW / -4MM OFFSET 32MM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 3673154
• MDR Text Key: 15810425
• Report Number: 1644408-2014-00151
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051075
• 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: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 508-32-103
• Device Lot Number: 864C1388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2014
• 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: 506-03-114,LOT 831C1159; 508-00-032,LOT 855C1267; 506-03-126,LOT 834C1136; 506-03-130,LOT 835C1127; 510-00-010,LOT 980F1093; 508-32-104,LOT 866C1755
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR