MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND HUMERAL SPACER +9MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL SPACER

Model Number 130730009

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/04/2021

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

The patient was revised due to present of infection.I&d washout with implant exchange were performed.All components had solid fixation.Original implantation was (b)(6) 2020.She had another washout in (b)(6) 2021.Doi: (b)(6) 2020.(b)(6) 2021 (glenosphere, metaglene and pe cup dor: (b)(6) 2021.Right 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.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DXTEND HUMERAL SPACER +9MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL SPACER
• 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: 12861776
• MDR Text Key: 281151829
• Report Number: 1818910-2021-26195
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027348
• UDI-Public: 10603295027348
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 130730009
• Device Catalogue Number: 130730009
• Device Lot Number: 5378222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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 STAND PE CUP D38 +3MM; XTND GLENO ECC D38MM +2MM
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female