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

Catalog Number 508-00-032

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 04/02/2015

Event Type  Injury  

Event Description

Revision surgery - due to the patient being a little short and needing to have a thicker poly placed in the joint.

Manufacturer Narrative

Concomitant part/lot number: 508-00-004,lot a000007 was incorrect on the initial mdr.Should be: 508-00-004,lot 39465l13.Manufacturer narrative: the reason for this revision surgery was reported as the patient was a little short and needed to have a thicker poly.The length of in vivo service was almost 5 years.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.Initial or prolonged hospitalization was required.The device was disposed of at the hospital and not made available to (b)(4) 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 there have been 133 prior complaints reported against this part; summary of investigations: 1 fit, 1 locking mechanism damaged, 1 contaminants in blister/pouch, 1 broke/cracked/damaged, 1 surface finish, 1 revision surgery, 1 device failed, 56 dislocation, 1 wear/excessive wear, 6 pain, 31 infection, 9 trauma, 17 stability/poor joint, 1 fixation/poor implant to bone, 2 malpositioned, 2 dislocation, 1 other.This is the third complaint against this lot.The revision surgery is the result of the patient being a little short and needed to have a thicker poly.No other conditions relating to this event could be determined with confidence.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: 4723678
• MDR Text Key: 5584410
• Report Number: 1644408-2015-00332
• 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: 04/02/2015

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: 02/28/2015
• Device Catalogue Number: 508-00-032
• Device Lot Number: A1000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 04/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2010
• 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: 506-00-008, LOT A1000003
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR