MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX54OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887354

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Sepsis (2067); Fibrosis (3167); No Code Available (3191)

Event Date 05/09/2012

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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 claim submission form, sticker sheets and medical records received via cd shipment last (b)(6) 2019.After review of medical records, the patient was revised to address infection, sepsis and to place an antibiotic spacer.Operative findings include large pockets of pus, abscesses and minor metal stains in the soft tissues but no gross evidence of metallosis.A trochanteric osteotomy was required to remove the stem which caused the proximal medial femoral cortex to fracture, fragment and shatter.Two synthes cables were required.Competitor cement spacer was used.Pathology reports indicate fibrosis and marked acute inflammation.Doi: (b)(6) 2006 - dor: (b)(6) 2012 (right hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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).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.

• Brand Name: PINNACLE MTL INS NEUT36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8701292
• MDR Text Key: 148071194
• Report Number: 1818910-2019-96053
• 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: other
• Type of Report: Initial,Followup
• Report Date: 05/27/2019

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: 05/31/2011
• Device Catalogue Number: 121887354
• Device Lot Number: 2155110
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 80