MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND SCREW LOCK D4.5X24MM; DELTA XTEND IMPLANTS : SCREWS

Model Number 130790024

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/27/2021

Event Type  Injury  

Event Description

Patient was revised due to loosening of all components at the bone to implant interface.Doi: (b)(6) 2019 dor: (b)(6) 2021 right knee.

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.

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 ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork LS11 8DT; EI LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12820629
• MDR Text Key: 280825980
• Report Number: 1818910-2021-25194
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295027836
• UDI-Public: 10603295027836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 130790024
• Device Catalogue Number: 130790024
• Device Lot Number: 5348517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 11/25/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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 MOD EPI 1 ECC RIGHT HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND STAND PE CUP D38 +6MM; METAGLENE LONG PEG +10MM; UNK SHOULDER HUMERAL STEM DELTA XTEND; XTND GLENO D38MM +2MM
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female