MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. RSP SHOULDER; SOCKET, INSERT 32MM STD. RSP HUMERAL

Catalog Number 508-00-032

Device Problems Failure To Adhere Or Bond (1031); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 05/18/2015

Event Type  Injury  

Event Description

Revision surgery - the patient's shoulder dislocated due to soft tissue not holding into place around the unit.

Manufacturer Narrative

The reason for this revision surgery was the patient's shoulder dislocated.The length of in vivo service was 1.8 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 showed no non-conforming material reports associated with the component listed in the complaint.(b)(4).This root cause for the dislocation was reported as the patient's soft tissue not being able to stabilize the implant.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP SHOULDER
• Type of Device: SOCKET, INSERT 32MM STD. RSP HUMERAL
• 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: 4788060
• MDR Text Key: 5859678
• Report Number: 1644408-2015-00300
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

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: 10/30/2019
• Device Catalogue Number: 508-00-032
• Device Lot Number: 855C1903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2014
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR