MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*SLEEVE PRX ZTT, 16F-LRG; HIP FEMORAL SLEEVE

Catalog Number 550516

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Inadequate Osseointegration (2646); Not Applicable (3189)

Event Date 03/09/2018

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.

Event Description

The primary surgery was performed on (b)(6) 2008.It was reported that the revision surgery was performed on (b)(6) 2018 due to the loosening of the implanted stem in varus and loosening of the sleeve.The cup was decided to keep inside of the patient¿s hip joint.No further information was provided by the hospital.

Manufacturer Narrative

Product complaint #
=
> pc-(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.

• Type of Device: HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7398838
• MDR Text Key: 104422505
• Report Number: 1818910-2018-56711
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295175261
• UDI-Public: 10603295175261
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 550516
• Device Lot Number: 1869329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2018
• Date Device Manufactured: 04/29/2005
• 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 Outcome(s): Required Intervention