MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM -2; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-50-000

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

Patient Problems Muscular Rigidity (1968); Pain (1994); Renal Failure (2041); Weakness (2145); Anxiety (2328); Discomfort (2330); Depression (2361); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Pinnacle litigation and medical records received.Litigation alleges pain, discomfort, weakness, limited adl, stress, anxiety, depression, insomnia and ckd stage 3.After review of medical records the patient was revised to address pain and osteolysis.Mri confirm presence of ostial lysis around femur but no loosening.Clinical visit reported tenderness over greater trochanter, discomfort, instability, stiffness, difficulty adl, metalic streak artifact obscure the tendons, some cortical hypertrophy at the tip of the stem but no loosening.Doi: (b)(6) 2007; dor: (b)(6) 2018; 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: added: h6 (patient).Corrected: g1 (physical manufacturer).

• Brand Name: ARTICULEZE M HEAD 36MM -2
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10143912
• MDR Text Key: 194822643
• Report Number: 1818910-2020-13648
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033899
• UDI-Public: 10603295033899
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

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: 12/31/2010
• Device Model Number: 1365-50-000
• Device Catalogue Number: 136550000
• Device Lot Number: 2037621
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 07/17/2020
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36 MM -2; CORAIL2 STD SIZE 11; PINNACLE 100 ACET CUP 52 MM; PINNACLE MTL INS NEUT36IDX52OD; ARTICULEZE M HEAD 36 MM -2; CORAIL2 STD SIZE 11; PINNACLE 100 ACET CUP 52 MM; PINNACLE MTL INS NEUT36IDX52OD
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 57