MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DXTEND STAND PE CUP D42 +3MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Model Number 130742203

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994)

Event Date 12/17/2021

Event Type  Injury  

Event Description

Patient had primary reverse shoulder replacement and presented with painful, inflamed right shoulder.Physician determined that the shoulder was possibly infected and revision surgery performed to remove two components, take tissue and fluid samples for culture and carry out a thorough washout of the infected shoulder before replacing the explants.Doi: (b)(6) 2021, dor: (b)(6) 2021, right shoulder.

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

Additional information received indicated that there was no surgical delay reported.

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.

Event Description

Additional information received indicated that the infection was confirmed.

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 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.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: e4.

• Brand Name: DXTEND STAND PE CUP D42 +3MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• 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: 13117867
• MDR Text Key: 282962065
• Report Number: 1818910-2021-29035
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295027539
• UDI-Public: 10603295027539
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 12/30/2021

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
• Device Operator: Health Professional
• Device Model Number: 130742203
• Device Catalogue Number: 130742203
• Device Lot Number: 5378914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/12/2022; 02/16/2022
• Supplement Dates FDA Received: 01/18/2022; 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 ECC D42MM; DXTEND STAND PE CUP D42 +3MM
• Patient Outcome(s): Required Intervention
• Patient Sex: Male