MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DXTEND SCREW LOCK D4.5X24MM; DELTA XTEND IMPLANTS : SCREWS

Model Number 130790024

Device Problems Fracture (1260); Loss of Osseointegration (2408)

Patient Problems Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 09/07/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.(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

Delta xtend claim letter record received.Claim letter alleged pain.Radiographs revealed the screws holding the glenoid fractured causing the component to migrate.On (b)(6) 2017, the patient underwent a primary uncemented reverse right total shoulder replacement due to rotator cuff arthropathy with degenerative osteoarthritis.There were no indicated complications during the operation.Four screws were used during the primary operation.The primary product information can be found on pages 10 and 11 of the medical records.Doi: (b)(6) 2017, dor: (b)(6) 2018, unknown shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DXTEND SCREW LOCK D4.5X24MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10493718
• MDR Text Key: 205666450
• Report Number: 1818910-2020-19485
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027836
• UDI-Public: 10603295027836
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 130790024
• Device Catalogue Number: 130790024
• Device Lot Number: 5297455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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: DXTEND GLENOSPHERE STD D38MM; DXTEND METAGLENE; DXTEND MOD CENT EPI 1 HA; DXTEND MODULAR HUM STEM D10 HA; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X24MM; DXTEND STAND PE CUP D38 +3MM; DXTEND GLENOSPHERE STD D38MM; DXTEND METAGLENE; DXTEND MOD CENT EPI 1 HA; DXTEND MODULAR HUM STEM D10 HA; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X24MM; DXTEND STAND PE CUP D38 +3MM
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Race: White