MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number 136532000

Device Problem Material Disintegration (1177)

Patient Problems Cardiac Arrest (1762); Infarction, Cerebral (1771); Tissue Damage (2104); No Code Available (3191)

Event Date 04/12/2005

Event Type  Injury  

Manufacturer 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 will be filed as appropriate.

Event Description

Ppf alleges stroke/heart attack, metal wear and metallosis before first revision.

Manufacturer Narrative

This is a duplicate report.1818910-2012-22827 is being retracted as it is reported duplication.1818910-2012-22826 will be kept for investigation purposes.

• Brand Name: S-ROM M HEAD 36MM +3
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8210334
• MDR Text Key: 131855860
• Report Number: 1818910-2019-79612
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295033387
• UDI-Public: 10603295033387
• Combination Product (y/n): N
• PMA/PMN Number: K120599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2008
• Device Catalogue Number: 136532000
• Device Lot Number: 1115285
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 07/16/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR