MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +8.5; HIP FEMORAL HEAD

Catalog Number 136553000

Device Problems Failure to Align (2522); Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Joint Swelling (2356); Ambulation Difficulties (2544)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

Oct 18, 2017: litigation record received.Litigation alleges pain.There is no report of revision at this time.

Manufacturer Narrative

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 code(s) 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.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.

Manufacturer Narrative

(b)(4).

Event Description

In addition to what was previously alleged, pfs alleges walking difficulty and left leg is approximately 35 degrees turned to left out of line on the right leg.After the review of medical records, it was reported that had bursitis.There was no reported revision.Added new associated contacts.

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.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.Depuy considers the investigation closed.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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: ARTICULEZE M HEAD 36MM +8.5
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7038422
• MDR Text Key: 92284647
• Report Number: 1818910-2017-29127
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2007
• Device Catalogue Number: 136553000
• Device Lot Number: YKM28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2002
• 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: 88 YR
• Patient Weight: 84