MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US STAND CUP TRIAL D42 +3MM; EXTREMITY INSTRUMENTS : HUMERAL TRIALS

Model Number 2307-42-403

Device Problems Device-Device Incompatibility (2919); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

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

During the surgery of shoulder prosthesis with delta xtend, the surgeon performed the trial with the trial cup standard size 42 +3.After performing it was quite difficult to remove the trial cup, and during the procedures of removing this trial cup was damaged on the edges.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination, therefore unavailable for a physical evaluation.However photographs were provided.Upon visual inspection of the photographs, some areas of shaved/shredded material around the outside edge of the device were noted.Additionally, nicks and other witness marks that appear to be consistent attempts of extraction were noted.The assembly/disassembly allegation cannot be evaluated thru a photograph.Based on the visual examination of the photographs, the complaint was partially confirmed.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: STAND CUP TRIAL D42 +3MM
• Type of Device: EXTREMITY INSTRUMENTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12510900
• MDR Text Key: 272672113
• Report Number: 1818910-2021-20695
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295115885
• UDI-Public: 10603295115885
• Combination Product (y/n): N
• PMA/PMN Number: K170748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2307-42-403
• Device Catalogue Number: 230742403
• Device Lot Number: 5367375
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1