MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX56OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-356

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

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); No Code Available (3191)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pcf and medical records received. After review of medical records, patient was revised to addressed painful left metal on metal hip replacement and limping more. Operatives notes indicated copious amount of thick dark fluid extruded from the joint consistent with severe metallosis of the hip. There is a dead tissue around posterior and anterior portion. Exposed the femoral stem, there was some erosion of the bone around the proximal portion of the stem, there is no evidence of loosening and no impingement in the hip and found to be stable. Doi: (b)(6) 2006; dor: (b)(6) 2017 left hip.

• Brand Name: PINNACLE MTL INS NEUT36IDX56OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9653028
• MDR Text Key: 188206867
• Report Number: 1818910-2020-03690
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/31/2011
• Device Model Number: 1218-87-356
• Device Catalogue Number: 121887356
• Device Lot Number: 2165148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/31/2020 Patient Sequence Number: 1