MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MBLOC HUM EPI 1 D8 LG; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	130708110
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/28/2019
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.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
Patient was revised to address loosening of the stem at the cement to implant interface.Cement manufacturer is (b)(4).(b)(6) 2019 surgery was a revision.A 8mm long monobloc delta reverse cemented stem was implanted.Patient dislocated and was referred to the surgeon.There was a 9mm spacer and a 6mm std cup that were removed.The 38mm glenosphere was removed and replaced with a 42mm glenosphere.Doi: (b)(6) 2019, dor: (b)(6) 2019 right shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the device associated with the reported event was not received at the investigation site for evaluation.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.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 D8 LG
• 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: 8436780
• Report Number: 1818910-2019-87870
• Device Sequence Number: 2205671
• Product Code: KWS
• UDI-Device Identifier: 10603295027119
• UDI-Public: 10603295027119
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K021478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 130708110
• Device Lot Number: 5307321
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/25/2019
• 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: 82 YR