MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 HUDSON ADAPTER; KNEE INSTRUMENT/TRIAL

Catalog Number 152400000

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(b)(4).Followup with the complainant has been conducted for the lot number, and the information is not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

During surgical procedure, the surgeon encountered difficulties in the passage of the reamers, as they were systematically disengaged from the handle and remained blocked inside the diaphysis.The problem came from the intermediate piece, hudson adapter ref (b)(4).

Manufacturer Narrative

Investigation has identified that the product is not depuy product.Therefore, we are rejecting this report.

Manufacturer Narrative

This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

The investigation has been reopened because it has been determined that this product is, in fact, depuy product and will be investigated as such.Depuy will notify the fda of the results of the investigation upon its completion.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

Additional narrative: during surgical procedure, the surgeon encountered difficulties in the passage of the reamers, as they were systematically disengaged from the handle and remained blocked inside the diaphysis.The problem came from the intermediate piece, hudson adapter ref (b)(4).Voided (b)(6) 2017 this complaint will be voided as it has been determined that no depuy synthes product is involved in this event (only competing products are involved).Update (b)(6) 2017 it was confirmed that the product was purchased by depuy (b)(4) to put in the loan kits.Depuy (b)(4) is distributor for this product, the complaint is therefore not voided.Examination of the returned device(s) confirms the reported event.Product problem has not been identified.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HUDSON ADAPTER
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6390701
• MDR Text Key: 69439462
• Report Number: 1818910-2017-14253
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 152400000
• Device Lot Number: 5005500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1