MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; SOCKET, SHELL NEUTRAL RSP

Catalog Number	508-00-000
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the modular shell disassociating from the stem.The problem was that the original surgeon did not impact the shell hard enough to the stem to lock it in.We replaced the shell, liner, and glenosphere and the outcome was successful.
Additional Manufacturer Narrative
Patient identifier (b)(6) and it's mfr report number 1644408-2017-00271 are being voided; it will not have additional information.Patient identifier (b)(6) was found to be a duplicate of patient identifier (b)(6) that was filed on 31 mar 2017.Patient identifier 0(b)(6) mfr report number is 1644408-2017-00201.

• Brand Name: RSP SHOULDER
• Common Device Name: SOCKET, SHELL NEUTRAL RSP
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6451419
• Report Number: 1644408-2017-00271
• Device Sequence Number: 874920
• Product Code: KWS
• UDI-Device Identifier: 00888912024600
• UDI-Public: (01)00888912024600
• Combination Product (Y/N): N
• PMA/510(K) Number: K041066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 508-00-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 506-03-118; 506-03-122; 508-00-032; 508-32-101
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 61 YR