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

Model Number 1307-62-142

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 09/15/2020

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 surgeon used the delta extend exclusively for all his primary and reverse shoulders.This is the first time he has used the new short post on the glenospheres.He uses the guide wire every time he implants them.This time he had a hard time aligning the post.When he was inline and started to screw in the post.We could here the distinctive squeak when the threads were engaged.The glenospheres would not advance.He removed it and evaluated the glenoid and removed any osteophytes and tissue that might impinge in the two implants.He inserted once again and the threads started to strip.He wanted another glenospheres so the nurse opened to the field.Same as the first it started to strip again.We came to the conclusion that the metaglene may be damaged.He removed and replaced with a new one.He also implanted a third glenospheres and that finally seated properly.The patient wasn't injured.The surgery time was extended by a hour.Right knee.

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.

Event Description

05 oct 2020: additional information was received from g.Padilla, sales rep, on september 30,2020 at 6:22 pm stating "this was my case that i covered.He had an issue with short post.I had two of the posts cross thread.He used a guide wire to seat the glenosphere.".

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned devices confirmed the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation was performed for the finished device d19053281, and no non-conformances/manufacturing irregularities were identified.B1 (adverse event) and b2 should not have been checked.

• Brand Name: XTND GLENO D42MM +2MM
• Type of Device: 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: 10594092
• MDR Text Key: 208797342
• Report Number: 1818910-2020-21008
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295502500
• UDI-Public: 10603295502500
• Combination Product (y/n): N
• PMA/PMN Number: K183077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1307-62-142
• Device Catalogue Number: 130762142
• Device Lot Number: D19053281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR