MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 50MM; HIP ACETABULAR CUP

Catalog Number 121722050

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

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Pain (1994); Tissue Damage (2104); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 02/16/2015

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.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).

Event Description

Litigation alleges patient suffers from pain, discomfort and elevated toxic metal ions.Update ad 5 sep 2018.(b)(4) has been re-opened under (b)(4) due to receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges bone fracture, abductor muscle repair, metallosis and metal wear.Added unknown hip implant to capture the allegation of a bone fracture as its unknown where the fracture was.If/when more information is received, the pc will be updated as needed.Doi: (b)(6) 2008; dor: (b)(6) 2015 (left hip).

Event Description

Ppf alleges limited mobility.After review of medical records, patient was revised to address post left total hip replacement with metal on metal implant in 2008; elevated cobalt and chromium levels with metallosis left hip and chronic pain.Intraoperative findings reported greater trochanteric fracture and loss of abductor tendon attachment to the left greater trochanter as well as diffuse severe metallosis.Clinical history reported clicking sensation in the hip, cobalt levels is 22 and chromium levels is 10.7.Operative note reported black grayish fluid, scar tissue and fracture of greater trochanter.

Manufacturer Narrative

Product complaint # (b)(4).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.  additional narrative:    patient code: no code available (3191) used to capture (tendon injury).

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).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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE SECTOR II CUP 50MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9175410
• MDR Text Key: 173005011
• Report Number: 1818910-2019-109149
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• 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: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 121722050
• Device Lot Number: C2SDY1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 73