MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PINNACLE MTL INS NEUT40IDX60OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-460

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

Patient Problems Adhesion(s) (1695); Edema (1820); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Synovitis (2094); Tissue Damage (2104); No Code Available (3191)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). A follow up will be conducted to provide the legal plaintiff information for the initial reporter once the details are provided. (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

Medical records received. After review of medical records, it was indicated that patient mri showed some deterioration within the joint. The patient was then revised for failed right total hip. Operative notes reported that as soon as surgery went through capsule, there was a black fluid that came out. Surgeon went and remove some synovium, but everything was pretty much degenerated. Send some synovium and necrotic tissue to pathology. Surgeon then cleared as much of the scar tissue from around the hip. Surgeon removed a lot of necrotic sort o amorphous tissue typical of what we seen a metal reaction and there was a fair amount of brownish tinged fluid that is filled out when we opened the hip capsule. Head and liner were revised. Mri reported of pain, synovitis and osteolysis lab results for cocr level were below 7 ppb doi: (b)(6) 2008; dor: (b)(6) 2020; right hip.

• Brand Name: PINNACLE MTL INS NEUT40IDX60OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10600006
• MDR Text Key: 208970209
• Report Number: 1818910-2020-21066
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K06242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2012
• Device Model Number: 1218-87-460
• Device Catalogue Number: 121887460
• Device Lot Number: 2484613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/29/2020 Patient Sequence Number: 1

Treatment

12/14 ARTICUL 40MM M SPEC+5; CORAIL2 NON COL HO SIZE 15; PINNACLE 100 ACET CUP 60MM