MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; RSP, PRIMARY HUMERAL MONOBLOCK, 10MM X 108

Model Number	510-00-010
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient falling and fracturing their humerus at the portion of the stem.The surgeon revised it with a new stem and changed the glenosphere size for greater stability.
Additional Manufacturer Narrative
The reason for this revision surgery was due to a fracture.The previous surgery and the revision detailed in this investigation occurred 1.3 years apart.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.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was a serious risk 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 implant device history records (dhr) shows a non-conforming material report (ncmr) # 33857 associated with the concomitant part 510-00-010, reverse shoulder prosthesis (rsp), primary humeral monoblock, 10millimeter x108 which documents a nonconformance that out of a (b)(4) quantity lot, 1 item was scrapped due to forging line being greater than.040 in length on the stem.All remaining items in the lot met the design, fit and function requirements and were accepted.The device and its applicable concomitant devices were within their respective expiration dates at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to fracture.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.Agent has mentioned that the patient fell and had a fracture, it seems that the event may have been occurred due to patient non-compliance with medical instructions, patient activities, and lack of care 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: RSP, PRIMARY HUMERAL MONOBLOCK, 10MM X 108
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7477259
• Report Number: 1644408-2018-00377
• Device Sequence Number: 2156435
• Product Code: KWS
• UDI-Device Identifier: 00888912024822
• UDI-Public: (01)00888912024822
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K100741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

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: 10/21/2022
• Device Model Number: 510-00-010
• Device Catalogue Number: 510-00-010
• Device Lot Number: 980F1303
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 05/04/2018
• 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: 508-00-432, LOT 918F1943; 508-32-103, LOT 864C2451; 508-00-432, LOT 918F1943; 508-32-103, LOT 864C2451
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 59 YR