MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. RSP SHOULDER; RSP MONOBLOCK PRIMARY HUMERAL STEM 12 X 101MM

Catalog Number 510-00-012

Device Problems Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 04/21/2014

Event Type  Injury  

Event Description

Revision surgery - due to the patient popping in/out of socket; dislocating.The surgeon changed standard cup from 3 inches above shoulder fracture to 4 1/2.

Manufacturer Narrative

Disposed of.

Manufacturer Narrative

The reason for the revision was reported as the patient's shoulder was popping in -out of socket/dislocating after 38 days of patient use.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 (b)(4) complaint against the main contributor, first for this lot number.A definitive root cause for the popping in -out of socket/dislocating could not be determined with confidence.There is no information reported that showed a material, design, or manufacturing problem with the product.

• Brand Name: RSP SHOULDER
• Type of Device: RSP MONOBLOCK PRIMARY HUMERAL STEM 12 X 101MM
• 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: 3770615
• MDR Text Key: 4357526
• Report Number: 1644408-2014-00240
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100741
• 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: 04/21/2014

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: 02/28/2020
• Device Catalogue Number: 510-00-012
• Device Lot Number: 981F1080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2014
• Initial Date FDA Received: 04/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2014
• 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: (B)(4), LOT 142G1071; (B)(4), LOT 918F1048
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR