MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. RSP SHOULDER; STEM, HUMERAL, LONG, REVISION, RSP, SIZE6

Catalog Number	507-06-175
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/10/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - patient went to e.R.After a fall.On the x-ray, the stem looked dislocated but the surgeon was unable to tell orientation of the plastic cup on the x-ray.The surgeon attempted closed reduction which was unsuccessful.Open reduction revealed the trauma of the fall had loosened the stem.
Additional Manufacturer Narrative
The reason for this revision surgery was the dislocation/loosening of the shoulder stem.The length of the in-vivo service was 12.4 years.The complaint states the patient suffered a fall and x-rays indicated a dislocation of the shoulder stem.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 djo surgical for examination.A review of the device history records (dhrs) 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 (ncmr's) were associated with this part.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed to be non-product related.The root cause for dislocation and looseness was a patient fall.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions relating to this event could not be determined with confidence.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP SHOULDER
• Common Device Name: STEM, HUMERAL, LONG, REVISION, RSP, SIZE6
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 5480994
• Report Number: 1644408-2016-00105
• Device Sequence Number: 13572562
• Product Code: KWS
• UDI-Device Identifier: 00888912144070
• UDI-Public: (01)00888912144070
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K041066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2016

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: 03/31/2009
• Device Catalogue Number: 507-06-175
• Device Lot Number: 881691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2016
• Supplement Report FDA Received Date: 07/20/2016
• 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