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	Fitting Problem (2183)
Health Effect - Clinical Code	Not Applicable (3189)
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
Der states that the new 9mm cta humeral spacer would not screw into the implanted cemented mono block stem so the surgeon choose to cut the threads off the implant and only use the taper as a locking mechanism.No further information is available.
Additional Manufacturer Narrative
(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.Device history lot: product code 4chl636, lot number 1894788.Device history review: the dhr analysis of the batch 1894788 shows an initial conformance of this product regarding its specification.For this batch, there was no deviation or non-conformance.This batch was manufactured in june 2005.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: 7406626
• Report Number: 1818910-2018-56913
• Device Sequence Number: 16395728
• 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
• Report Source: company representative,health
• 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?: No
• Is this a Product Problem Report?: Yes
• 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: 06/12/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 90