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	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/15/2018
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
The patient was revised to address loosening of the unknown component at bone to cement and cement to implant interface.Depuy cement was used.Original fx reverse.Came back infected and doing a 2 stage.Abx spacer implanted.All parts removed.Don't have part number or lot on depuy 2 cement.Doi: (b)(6) 2017; dor: (b)(6) 2018; unknown side.
Additional Manufacturer Narrative
Pc-(b)(4).No device was received.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:5286673 the dhr analysis of the batch indicated shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.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: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7863770
• Report Number: 1818910-2018-68886
• Device Sequence Number: 11181985
• Product Code: HSD
• UDI-Device Identifier: 10603295027133
• UDI-Public: 10603295027133
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2018

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: 5286673
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/22/2018
• 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: 71 YR
• Patient Weight: 76