MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX58OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887358

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Discomfort (2330); Injury (2348); Joint Dislocation (2374); Test Result (2695); Cancer (3262)

Event Date 12/06/2010

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

Pinnacle mom litigation record received.Update nov 20, 2018: litigation alleges that the patient experienced pain, discomfort, suffering, injury, emotional distress, metal toxicity, and numerous dislocations requiring reductions.Patient passed away (b)(6) 2012 and the cause of death was recorded as "presumed natural causes" due to complications from his diagnosed multiple myeloma, bone cancer.

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.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).

• Brand Name: PINNACLE MTL INS NEUT36IDX58OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8200303
• MDR Text Key: 131526048
• Report Number: 1818910-2018-79251
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2012

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: 03/31/2011
• Device Catalogue Number: 121887358
• Device Lot Number: 2117214
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2012
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 03/14/2019; 12/12/2019
• Supplement Dates FDA Received: 03/26/2019; 12/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 104