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

Catalog Number	130710100
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Revised due to pain and impingement.The inferior screw had snapped, probably due to mechanical notching.Revised to a 42 eccentric glenosphere and 42/9 hmo poly.Significant lysis around both components as a result of the mechanical notching.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the complaint description reports a revison due to pain and impingement.The inferior screw had snapped, probably due to mechanical notching.No products were returned for this complaint.Based on the investigation performed no product defect was identified.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the dhr analysis of the batch 5243805/ product code 130710100, shows an initial conformance of these products with regards to the specification.For this batch, there was no deviation or non-conformance.(b)(4) parts were manufactured in february 2015.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DXTEND MBLOC HUM EPI 1 D10 STD
• Common Device Name: SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7292071
• Report Number: 1818910-2018-54002
• Device Sequence Number: 19105093
• Product Code: HSD
• UDI-Device Identifier: 10603295027133
• UDI-Public: 10603295027133
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 130710100
• Device Lot Number: 5243805
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 09/12/2018
• 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: 76 YR