MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121701054

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problems Host-Tissue Reaction (1297); Inflammation (1932); Pain (1994); Tissue Damage (2104); Discomfort (2330)

Event Date 10/19/2012

Event Type  Injury  

Manufacturer Narrative

(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

Litigation alleges severe pain, discomfort, inflammation, and elevated levels of cobalt chromium metal ions and particles in the blood and tissue surrounding the implant.**update** 4/16/2013- pfs and medical records received.Part/lot was provided.There is no new additional information that would affect the existing mdr decision.Update rec'd 4/16/2013-pfs and medical records received.After review of the medical records the revision operative note indicated the cup was also revised, but only because the metal liner wasn¿t able to be removed.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 8/28/2014.Update jan 12, 2018: pfs and medical records received.In addition to what were previously alleged, pfs alleges walking difficulty.After the review of medical records, it was stated that the patient was revised to address painful metal-on-metal left total hip replacement.Clinical notes reported synovitis.Added new associated contacts.Added stem due to reported high metal ions.No metal ion levels were reported.This complaint was updated on: january 26, 2017.

Manufacturer Narrative

Product complaint #: (b)(4).

Manufacturer Narrative

(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.

• Brand Name: PINNACLE 100 ACET CUP 54MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7237401
• MDR Text Key: 98878327
• Report Number: 1818910-2018-52640
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008569
• UDI-Public: 10603295008569
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2009
• Device Catalogue Number: 121701054
• Device Lot Number: Y76DN1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 07/25/2018; 09/27/2018
• Supplement Dates FDA Received: 07/26/2018; 09/27/2018
• Date Device Manufactured: 12/10/2004
• 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
• Patient Age: 37 YR
• Patient Weight: 77