MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. RSP SHOULDER; RSP HUM SOCKET INSERT, 36MM +4MM, SEMI

Catalog Number	508-01-436
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/07/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Second revision surgery - due to excess bone left in the patient; it was causing impingement/dislocation; no component failure present.
Additional Manufacturer Narrative
The reason for this second revision surgery was impingement and dislocation.The implant was in-vivo 4 months prior to this revision to correct the shoulder.The healthcare professional indicated there was a significant adverse event to the patient.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 (b)(4) for examination.A review of the device history records revealed no discrepancies or issues with the manufacturing history of this part.All parts were found to meet design and manufacturing specifications.No non-conforming material reports (ncmrs) were associated with this product.A review of the product complaint report history was reviewed and no trends or on-going issues were deemed to be present or in need of review.The complaint states the root cause for the impingement and dislocation was excess bone left in the shoulder.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP SHOULDER
• Common Device Name: RSP HUM SOCKET INSERT, 36MM +4MM, SEMI
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 5489738
• Report Number: 1644408-2016-00163
• Device Sequence Number: 445083
• Product Code: KWS
• UDI-Device Identifier: 00888912144292
• UDI-Public: (01)00888912144292
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2015

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2019
• Device Catalogue Number: 508-01-436
• Device Lot Number: 923F1901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2016
• Supplement Report FDA Received Date: 03/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 74 YR