MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 DXTEND MBLOC HUM EPI 1 D10 STD; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	130710100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that original surgery was a cemented reverse total shoulder arthroplasty for proximal humerus fracture, patient then fractured distal to the tip of the stem and surgeon plated the fractured.Eventually that repair failed and bone began to resorb.We took out stem and pe cup today and used a humeral allograft new bone and new implants on the humeral side.Doi: 2011; dor: (b)(6) 2018; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: DXTEND MBLOC HUM EPI 1 D10 STD
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cede 69801 ; FR 69801
• MDR Report Key: 7770032
• Report Number: 1818910-2018-66264
• Device Sequence Number: 2050505
• Product Code: KWS
• UDI-Device Identifier: 10603295027133
• UDI-Public: 10603295027133
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K021478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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 Catalogue Number: 130710100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 11/28/2018
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 97