MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 12/14 ARTICUL 40MM M SPEC+5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-06-000

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 in section e 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 withing 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.

Manufacturer Narrative

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.H10 additional narrative: corrected: e1, e2, e3.E3 initial reporter occupation: lawyer.

• Brand Name: 12/14 ARTICUL 40MM M SPEC+5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10600009
• MDR Text Key: 208971516
• Report Number: 1818910-2020-21068
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295032984
• UDI-Public: 10603295032984
• Combination Product (y/n): N
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: 1365-06-000
• Device Catalogue Number: 136506000
• Device Lot Number: 2532445
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORAIL2 NON COL HO SIZE 15; PINNACLE 100 ACET CUP 60MM; PINNACLE MTL INS NEUT40IDX60OD; CORAIL2 NON COL HO SIZE 15; PINNACLE 100 ACET CUP 60MM; PINNACLE MTL INS NEUT40IDX60OD
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 89