MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND GLENOSPHERE STD D42MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Model Number 130760142

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

(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 this was an rsa (reverse shoulder arthroplasty) treating rupture fracture in the proximal end of the humerus on (b)(6) 2020.After a metaglene was deployed, it was difficult to place the std glenosphere in question smoothly.So the surgeon deployed the std glenosphere in question without trial.The surgeon moved on to the rest of the procedure and finally inserted a trial +9 cup.However, the implants seemed rather loose, so he replaced the std glenosphere in question with a 42mm ecc glenosphere.This time the implants were properly balanced, and the procedure was completed less than 30 minutes.The device was brand new and the first use when the issue occurred.The surgeon commented as follows: it was difficult to place a stem due to the rupture fracture.Also, cement was used for treating the fracture.So, the stem was deployed a little lower.

Manufacturer Narrative

Product complaint # (b)(4).After further review, this was identified to be an intra-operative event so the previous submission of an implant disassociation isn't correct.Additional follow up is being conducted to determine if there was a deficiency with the glenosphere or it was just exchanged to provide a better fit for the patient.If/when additional information is received, another supplemental will be submitted.

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

• Brand Name: DXTEND GLENOSPHERE STD D42MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10683764
• MDR Text Key: 211494805
• Report Number: 1818910-2020-22376
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295027775
• UDI-Public: 10603295027775
• Combination Product (y/n): N
• PMA/PMN Number: K062250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130760142
• Device Catalogue Number: 130760142
• Device Lot Number: 5358646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND GLENOSPHERE STD D42MM; UNKNOWN SHOULDER METAGLENE; DXTEND GLENOSPHERE STD D42MM; UNKNOWN SHOULDER METAGLENE
• Patient Outcome(s): Required Intervention