MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 UNKNOWN SHOULDER NON-LOCKING SCREW; NON LOCKING BONE SCREW

Catalog Number UNK SHOULDER NON-LOCKING SCREW

Device Problem Osseointegration Problem (3003)

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

Event Date 02/24/2021

Event Type  Injury  

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

On (b)(6) 2021, dr.Revised a left reverse shoulder for infection.The reverse shoulder was implanted in this patient on (b)(6) 2020 by another dr.Cultures taken in clinic a week ago came back with growths this morning and dr.Elected to perform a two stage revision for infection.Upon exposing the left shoulder joint space, dr.Found the entire glenoid construct of a metaglene, four screws (indeterminable if the screws were locking or non locking, and lengths were indeterminable as well as were lot codes) and 38 eccentric glenoshpere, to be loose at the bone/implant interface.Dr.Was able to remove the entire glenosphere construct by hand.Dr.Remove the 38 +9 liner with an osteotome.Dr.Then removed the size 2 left epiphysis with an osteotome and mallet and the yellow screwdriver.Dr.Then removed the sz 12 standard distal stem with osteotomes and the t handle.The humeral construct was well fixed.Dr.Then created his own antibiotic spacer with non-depuy cement and implanted that.There were no delays in the case.No instrumentation broke during the case.There was no indication by the surgeon that he thought the implants didn¿t perform as expected.There was no cement present from previous, index surgery.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNKNOWN SHOULDER NON-LOCKING SCREW
• Type of Device: NON LOCKING BONE SCREW
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 11438317
• MDR Text Key: 240958765
• Report Number: 1818910-2021-04641
• Device Sequence Number: 1
• Product Code: HSD
• 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
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER NON-LOCKING SCREW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND MOD EPI 2 ECC LEFT HA; UNK SHOULDER GLENOSPHERE DELTA XTEND; UNK SHOULDER HUMERAL CUP DELTA XTEND; UNK SHOULDER HUMERAL STEM DELTA XTEND; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR