MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DXTEND METAGLENE; DELTA XTEND IMPLANTS : SHOULDER METAGLENE

Model Number 130760000

Device Problem Osseointegration Problem (3003)

Patient Problems Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/29/2021

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

It was reported that a depuy synthes sales consultant was notified prior to the case by a surgeon that the patient had fallen the previous week and re-injured the operative shoulder.Surgeon advised that he planned to revise the patient's injured shoulder and treat for possible infection.Upon further intraoperative evaluation, surgeon discovered that the metaglene, 4 locking screws and the glenosphere had all become dislodged from the patient's glenoid.Surgeon was able to extract all of these implants as on unit completely put together and undamaged.At this point, surgeon checked the humeral stem and epiphysis was determined that those implants remained well fixed and undamaged.Surgeon replaced the humeral cup poly and formed an antibiotic cement spacer to serve as a temporary fit prosthesis while the patient's infection will be treated.Due to questions about the stability and health of the patient's glenoid, surgeon asked for assistance from the depuy synthes trumatch shoulder solutions team to evaluate options and recommendations for the patient's glenoid following treatment of the infection.Doi: (b)(6) 2017 dor: (b)(6) 2021 left shoulder.

Manufacturer Narrative

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.

Event Description

Additional information received states that there's no other injuries to patient prior to the patient¿s fall were reported.The surgeon ordered a ct scan of the patient¿s left shoulder following the revision surgery to determine if the patient¿s glenoid could support a new metaglene and glenosphere with bone graft as needed and the best position to place it in.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 METAGLENE
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 11659453
• MDR Text Key: 246662400
• Report Number: 1818910-2021-07838
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027737
• UDI-Public: 10603295027737
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 130760000
• Device Catalogue Number: 130760000
• Device Lot Number: 5291577
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 04/13/2021; 05/27/2021
• Supplement Dates FDA Received: 04/20/2021; 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND GLENOSPHERE ECC D42MM; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND STAND PE CUP D42 +9MM
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR