MAUDE Adverse Event Report: GSOURCE GSOURCE; CUP PUSHER - BLACK DELRIN HEAD

Model Number 11.5" SHAFT 50MM HEAD

Device Problems Break (1069); Fracture (1260); Device Issue (2379)

Patient Problems Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)

Event Date 07/06/2015

Event Type  Injury  

Event Description

A (b)(6) male, on (b)(6) 2015, underwent reimplantation of right total hip replacement (s/p removal of right total hip replacement with insertion of antibiotic spacer on (b)(6) 2015 for infected right total hip replacement).Intra-operatively, on (b)(6) 2015, after removing the spacer head, it was noted that there was a round black disk within the cotyloid fossa.The disk was removed.The procedure was completed.The patient was discharged home with home care services on (b)(6) 2015.It was subsequently learned that the black disk was a small portion from the top of the cup pusher that was used during spacer placement and right total hip replacement removal on (b)(6) 2015.Apparently, a small portion of the instrument broke off and was retained.Due to its location, the portion of the disk wasn't visible on post-operative x-rays following the (b)(6) 2015 surgery.The post-operative course following the (b)(6) 2015 spacer surgery had been uneventful.Mfr#: 2249529-2015-00001.

• Brand Name: GSOURCE
• Type of Device: CUP PUSHER - BLACK DELRIN HEAD
• Manufacturer (Section D): GSOURCE; emerson NJ 07630
• MDR Report Key: 5179829
• MDR Text Key: 30222908
• Report Number: 5179829
• Device Sequence Number: 1
• Product Code: HXO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11.5" SHAFT 50MM HEAD
• Device Catalogue Number: Z1302 1301
• Device Lot Number: 336 1304
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/06/2015
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 88