MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 XTND GLENO D42MM +2MM; XTND GLENO : SHOULDER IMPLANT

Model Number	1307-62-142
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930); No Code Available (3191)
Date of Event	03/25/2020
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
Clinical notification received for revision of left total shoulder to address a surgical wound infection with deep extension to the joint.Date of implantation: (b)(6) 2020.Date of revision: (b)(6) 2020.(left shoulder).Treatment: humeral cup and glenosphere implants revised, to improve chance of infection eradication.
Additional 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.¿.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Primary operative notes (b)(6) 2020 indicate the patient received a left reverse total shoulder replacement due to irreparable rotator cuff tear.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2020 indicate the patient received a left total shoulder revision due to postoperative hematoma and infection, confirmed superficial abscess with communication to joint.Humeral cup and glenosphere implants revised.The surgery was completed without indication of complication by the surgeon.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  h10 additional narrative: added: b5 and h6 (patient code).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
Additional information received: 1.Implant insertion op notes.Reason for initial arthroplasty- patient had a failed rotator cuff repair of a very large tear and now had an irreparable tear with early glenohumeral arthropathy.Pain was severe and function limited.There are no pt reports since patient was rehabbing with home exercise and there were no reported falls or dislocation events.2.Implant removal/revision op notes.Reason for revision surgery- a large post-operative hematoma became erythematous and purulent material began draining from incision.Due to infection patient was irrigated and derided.There was a small area where this infection had begun to infiltrate the joint.Since the intraarticular fluid was not purulent and the humeral stem and metaglene well fixed, the glenosphere and poly cup were removed and new components placed.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.

• Brand Name: XTND GLENO D42MM +2MM
• Common Device Name: XTND GLENO : SHOULDER IMPLANT
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10049464
• Report Number: 1818910-2020-12013
• Device Sequence Number: 16852899
• Product Code: KWS
• UDI-Device Identifier: 10603295502500
• UDI-Public: 10603295502500
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K183077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/01/2020

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 Expiration Date: 07/31/2024
• Device Model Number: 1307-62-142
• Device Catalogue Number: 130762142
• Device Lot Number: D19081535
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 05/01/2020; 05/27/2020; 06/10/2020; 06/15/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 05/26/2020; 06/01/2020; 06/11/2020; 06/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DXTEND METAGLENE.; DXTEND MOD EPI 1 ECC LEFT HA.; DXTEND SCREW LOCK D4.5X36MM.; DXTEND SCREW LOCK D4.5X36MM.; DXTEND STAND PE CUP D42 +3MM.; GLOBAL UNITE STD STEM SZ 14.; DXTEND METAGLENE; DXTEND MOD EPI 1 ECC LEFT HA; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND STAND PE CUP D42 +3MM; GLOBAL UNITE STD STEM SZ 14
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 57