MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 300 ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121703052

Device Problem Loss of Osseointegration (2408)

Patient Problems Hematoma (1884); Inflammation (1932); Pain (1994); Tissue Damage (2104); Discomfort (2330); Deformity/ Disfigurement (2360); Blood Loss (2597); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).

Event Description

Complaint description: oct 3, 2017: claim letter received requesting for compensation for damages from injuries due to a defective depuy hip implant.There is no adverse event or revision reported.Update litigation alleges friction and wear in the devices causing elevated metal ions, pain, discomfort, inflammation, internal bleeding, mass that was a hematoma, suffering, disability, physical impairment, disfigurement, and mental anguish.Doi: (b)(6) 2008; dor: (b)(6) 2017; right hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE 300 ACET CUP 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8463971
• MDR Text Key: 140291203
• Report Number: 1818910-2019-88955
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008651
• UDI-Public: 10603295008651
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

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: 04/24/2017
• Device Catalogue Number: 121703052
• Device Lot Number: BR1CS1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 07/31/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR