MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND MBLOC HUM EPI 1 D10 STD; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS

Model Number 130710100

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930)

Event Date 10/20/2021

Event Type  Injury  

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 Description

Revision of a delta xtend due to infection, loosening, and periprosthetic fracture (which appeared to have healed).Upon exposure it was very clear that the infection was widespread and was affecting all components.All components were removed and a cement spacer was implanted while the infection clears.Primary surgery was done on (b)(6) 2016.Female, right side.Prior to this the patient had a proximal humeral fracture.I can't recall the exact date.This was addressed using a proximal humeral plate which subsequently failed leading to the delta xtend in 2016.The patient had fractured just distal to the humeral stem, but by the time the revision was booked it appeared to have healed.Stem was loose.Loosening was mostly attributed to infection.The periprosthetic fracture was talked about being a contributing factor to loosening.All components were removed and a spacer was cemented in.

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 MBLOC HUM EPI 1 D10 STD
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12740708
• MDR Text Key: 279689402
• Report Number: 1818910-2021-24211
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027133
• UDI-Public: 10603295027133
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K120174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130710100
• Device Catalogue Number: 130710100
• Device Lot Number: 5252308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• 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 D42MM; DXTEND HUMERAL SPACER +9MM; DXTEND MBLOC HUM EPI 1 D10 STD; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X48MM; DXTEND SCREW LOCK D4.5X48MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D42 +6MM; DXTEND GLENOSPHERE STD D42MM; DXTEND HUMERAL SPACER +9MM; DXTEND MBLOC HUM EPI 1 D10 STD; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X48MM; DXTEND SCREW LOCK D4.5X48MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D42 +6MM
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female