MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 LATERALIZD HUM CUP DIA 36+6MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Catalog Number	4CHL636
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/12/2018
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
The patient was revised to address pain and instability.The surgeon did a reverse cta left shoulder for this patient around 2007.Today the surgeon operated on patient to revise the poly cup.Intra-operatively the poly was found to be worn severely.The surgeon said the implants were well fixed and decided to add a 9mm spacer and a 36+6 retentive cup.This trial construct appeared to be stable intra-operatively.Doi: 2007; dor: (b)(6) 2018; left knee.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.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.

• Brand Name: LATERALIZD HUM CUP DIA 36+6MM
• 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: 7395850
• Report Number: 1818910-2018-56676
• Device Sequence Number: 723756
• Product Code: KWS
• UDI-Device Identifier: 10603295170471
• UDI-Public: 10603295170471
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K021478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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: 4CHL636
• Device Lot Number: 1894788
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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 Weight: 90