MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND SCREW LOCK D4.5X48MM; DELTA XTEND IMPLANTS : SCREWS

Model Number	130790048
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 D4.5X48MM
• Common Device Name: DELTA XTEND IMPLANTS : SCREWS
• 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: 12740735
• Report Number: 1818910-2021-24206
• Device Sequence Number: 12008301
• Product Code: KWS
• UDI-Device Identifier: 10603295027874
• UDI-Public: 10603295027874
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K120174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 130790048
• Device Catalogue Number: 130790048
• Device Lot Number: 5267115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female