MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND SCREW NO LOCK D4.5X36MM; DELTA XTEND IMPLANTS : SCREWS

Catalog Number	130770036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); No Code Available (3191)
Date of Event	11/13/2018
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
Customer reports: uncoupling of the glenosphere from the genoid base (metaglene) of the right shoulder prosthesis.Metallosis was found in the articulation during the revision surgery.Screw breakage of the glenosphere occured during the extraction of the implant.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.Post market surveillance is per sep 419.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DXTEND SCREW NO LOCK D4.5X36MM
• Common Device Name: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8204356
• Report Number: 1818910-2018-79436
• Device Sequence Number: 233882
• Product Code: HWC
• UDI-Device Identifier: 10603295027812
• UDI-Public: 10603295027812
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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: 130770036
• Device Lot Number: 5251072
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 02/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 77