MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136536710

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Joint Dislocation (2374); Test Result (2695); No Code Available (3191)

Event Date 07/23/2013

Event Type  Injury  

Manufacturer Narrative

Product complaint : (b)(4).Initial reporter occupation: lawyer.(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

Patient was revised to address disassociation of the liner from the cup.A screw also broke during the attempt to remove it.After review of the medical records for mdr reportability, the revision operative note indicated black debris from the head riding on the cup, disassociation, and the screw head was worn down due to the head riding on it.It was noted reported to be broken.Ppf alleges elevated metal ions and dislocation.After review of medical records, clinic visits reported of squeaking and dislocation.Stem was already reported in 1st revision.Doi: (b)(6), 2007 (cup/screw); doi: (b)(6) 2013 (liner) - dor: (b)(6) 2013 (right hip) second revision.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint (b)(4).Investigation summary: 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: DLT TS CER HD 12/14 36MM +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9295754
• MDR Text Key: 165590993
• Report Number: 1818910-2019-115183
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295033653
• UDI-Public: 10603295033653
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 136536710
• Device Lot Number: 3544217
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 82