MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD 8010379 ARTICULEZE M HEAD 36MM -2; HIP FEMORAL HEAD

Catalog Number 136550000

Device Problem Misconnection (1399)

Patient Problem No Code Available (3191)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

After several attempts, two heads would not mate with the stem.

Manufacturer Narrative

After several attempts, two heads would not mate with the stem.Visual examination of the returned devices finds nothing outward to suggest product problem.The devices were produced several months apart and are not from the same lot.No other reports found against the femoral head product/lot code combinations.Additionally, research using the as400 system indicates that several pieces from the reported lots have been delivered, and, as no additional reports have been received, can be reasonably assumed implanted without issue.Information was repeatedly requested for the third femoral head and femoral stem.No information was returned.Product problem has not been identified.Based on the performed investigation, the need for corrective action has not been indicated.Monitor via trending (b)(4).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.

• Brand Name: ARTICULEZE M HEAD 36MM -2
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5748017
• MDR Text Key: 48116601
• Report Number: 1818910-2016-22119
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 136550000
• Device Lot Number: 8296065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR