MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 X-LINK HIMO HUM CUP 42+6; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Catalog Number	130742706
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Not Applicable (3189)
Date of Event	07/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional 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
The patient was revised to address dislocation.The original 42mm standard glenosphere was exchanged for a 42mm eccentric glenosphere and the original size 42 +6mm high mobility humeral cup was exchanged for a size 42 +6mm retentive humeral cup.Doi: (b)(6) 2018, dor: (b)(6) 2018, left shoulder.
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: X-LINK HIMO HUM CUP 42+6
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7792708
• Report Number: 1818910-2018-66971
• Device Sequence Number: 19216329
• Product Code: HSD
• UDI-Device Identifier: 10603295027669
• UDI-Public: 10603295027669
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K062250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/21/2018

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: 130742706
• Device Lot Number: 628340
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/07/2018
• 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