MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND STAND PE CUP D38 +6MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Catalog Number 130738206

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); No Code Available (3191)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event 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.

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).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 STAND PE CUP D38 +6MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8204377
• MDR Text Key: 131661503
• Report Number: 1818910-2018-79438
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027379
• UDI-Public: 10603295027379
• Combination Product (y/n): N
• PMA/PMN Number: K120174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 130738206
• Device Lot Number: 5232423
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 77