MAUDE Adverse Event Report: DEPUY FRANCE SAS¿ 3003895575 DXTEND MBLOC HUM EPI 2 D10 STD; SHOULDER HUMERAL STEM/EPIPHYSIS

Catalog Number	130710200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Synovitis (2094)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Der states that the sales rep reported that the surgeon called her that the shoulder-delta prosthesis had possible metastasis and rejection.It was also stated that the surgeon would need to extract the material as soon as possible from the patient, and that removal has already occurred.It was also indicated that the patient was without prosthesis and with shoulder fallen.It was also stated that all the material that make up the prothesis was described and was sent to evaluate.Is it important to verify if the metalosis issue was really generated by the prosthesis implanted.It was also stated that the patient presented pain after the examination was diagnosed with metalosis.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Additional Manufacturer Narrative
Examination of the returned device id not reveal any evidence oif product error.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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 2 D10 STD
• Common Device Name: SHOULDER HUMERAL STEM/EPIPHYSIS
• Manufacturer (Section D): DEPUY FRANCE SAS¿ 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 6866342
• Report Number: 1818910-2017-24640
• Device Sequence Number: 16449310
• Product Code: HSD
• UDI-Device Identifier: 10603295027157
• UDI-Public: 10603295027157
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/15/2017

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 Catalogue Number: 130710200
• Device Lot Number: 5236921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 10/02/2017; 09/15/2017; 12/08/2017; 12/08/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 10/04/2017; 10/10/2017; 12/12/2017; 12/27/2017
• 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