MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. RSP SHOULDER; STEM, HUMERAL 10MM RSP

Catalog Number	506-00-010
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/09/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to product failure; the morse taper between shell and stem disassociated.
Additional Manufacturer Narrative
The reason for this revision surgery was dissociation of the socket and stem at the taper.The shell and stem implants were in the patient for about 6 weeks prior to revision.This was the second revision for this patient.On (b)(6) 2016 the patient was revised to a thicker liner due to dislocation (reference (b)(4).) there is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.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.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records (dhr's) revealed no non-conforming material reports (ncmr's) associated with any of the components listed in the complaint.All morse taper angles and gage point diameters were inspected 100%.The dhrs evidence that all critical dimensions and specifications were met when these products were released from djo surgical.The complaint history for this part was reviewed.This is the first complaint for each of the affect lots.There are 8 previous reports of dissociation for the stem and shell part numbers given.There is no indication of an adverse trend.This investigation is limited in scope because the explanted products were not returned to djo surgical and a definitive root cause cannot be determined.There was no information reported that evidences a material, design, or manufacturing problem with the product.Factors not related to the implant can play a role in dissociation failure such as foreign material in the morse taper during assembly, or trauma.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 10MM RSP
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 5548480
• Report Number: 1644408-2016-00189
• Device Sequence Number: 520217
• Product Code: KWS
• UDI-Device Identifier: 00888912024396
• UDI-Public: (01)00888912024396
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2017

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 Expiration Date: 12/31/2020
• Device Catalogue Number: 506-00-010
• Device Lot Number: 816C1199
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2016
• Supplement Report FDA Received Date: 01/07/2017
• 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: 415-00-120,LOT 7715101-12
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR