MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND

Catalog Number UNK SHOULDER HUMERAL EPIPHYSIS

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.(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

The patient was revised to address infection and loosening of all components at bone to cement interface.Metaglene, 4 screws, glenosphere, cup, spacer, epiphysis, and stem were removed.A competitor cement spacer was implanted.No implant part numbers or lot numbers available.No further information is available.Doi: (b)(6) 2017, dor: (b)(6) 2020, left shoulder.

• Brand Name: UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND
• Type of Device: SHOULDER HUMERAL EPIPHYSIS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10853416
• MDR Text Key: 216667201
• Report Number: 1818910-2020-24796
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL EPIPHYSIS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK SHOULDER GLENOSPHERE DELTA XTEND; UNK SHOULDER HUMERAL CUP DELTA XTEND; UNK SHOULDER HUMERAL STEM DELTA XTEND; UNK SHOULDER LOCKING SCREW DELTA XTEND; UNK SHOULDER LOCKING SCREW DELTA XTEND; UNK SHOULDER METAGLENE DELTA XTEND; UNK SHOULDER NON-LOCKING SCREW DELTA XTEND; UNK SHOULDER NON-LOCKING SCREW DELTA XTEND; UNKNOWN SHOULDER IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR