MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 56MM METAL ON METAL SHELL; S-ROM HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 859838

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 12/05/2017

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.

Event Description

Revision hip, dr (b)(6), (b)(6) hospital (b)(6) 2017.Primary implant date (b)(6) 2002.The patient had been good until recently when they have been suffering with severe hip pain.Dr (b)(6) removed the cup, liner and head.He replaced the cup and liner with zimmer biomet implants and a depuy synthes head.Doi: (b)(6) 2002;.Dor: (b)(6) 2017; unknown hip.

Manufacturer Narrative

Investigation summary: no device associated with this report was received for examination.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.Device history lot: 483199 device history review: no anomalies 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: 56MM METAL ON METAL SHELL
• Type of Device: S-ROM HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds IN LS11 8DT; UK LS11 8DT
• 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 46582-0988 ; 5743725905
• MDR Report Key: 7155046
• MDR Text Key: 96057718
• Report Number: 1818910-2017-52738
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K001523
• 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: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 859838
• Device Lot Number: 483199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2018
• Date Device Manufactured: 02/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention